Cleanroom Glove Selection Guide USP 795 797 800

SOSCLEANROOM | GLOVE SELECTION & COMPOUNDING PROTECTION

The Right Glove Protects the Product, the Process & the Person.

An evidence-based glove selection and qualification guide for USP <795> nonsterile compounding, USP <797> sterile compounding, USP <800> hazardous-drug handling, and related cleanroom operations. Compare materials, sterility, chemotherapy permeation testing, glove fit, double-gloving, aseptic handling and procurement documentation.

Find the right glove ↓ Glove sizing & fit guide →

First principles

Begin with the hazard assessment, not a glove brand or an ISO number.

The glove is a moving, high-contact interface between the operator, preparation, equipment, clothing and surrounding environment. One product can be sterile but inadequately protective against a hazardous drug; another can resist a solvent but carry unacceptable particles or be packaged for general laboratory use. Selection therefore requires multiple independent decisions.

Patient / product

Do we need a sterile barrier?

Confirm whether a sterile preparation or aseptic task requires sterile, powder-free gloves, approved aseptic donning and regular glove disinfection.

Employee

What chemical or hazardous-drug exposure is possible?

Identify drugs, concentration, solvents and exposure mode. Check drug-specific permeation data, glove test standard and required glove layers.

Environment

What contamination can the glove introduce?

Review glove surface cleanliness, ions, extractables, particles, packaging and whether the product is appropriate for the applicable operation.

Operator

Can the worker perform critical tasks without tearing or slipping?

Measure and trial the actual size, cuff length, dexterity, grip and fit in both single- and double-glove configurations.

Procedure

How will it be handled and changed?

Define hand hygiene, staging, donning, cuff interfaces, IPA compatibility, glove changes, doffing and waste disposal.

Quality / purchasing

What evidence supports approval?

Keep the technical data sheet, exact SKU and size, sterile/chemo claims, lot and expiry traceability and approved substitute rules.

The central rule

A glove labeled “ISO 5,” “sterile,” “chemotherapy-tested,” “powder-free,” or “nitrile” has described one characteristic—not demonstrated every requirement of a complete compounding or cleanroom procedure.

Regulatory decision table

USP795 - 797 - 800 answer different glove questions.

Activity / governing framework	Baseline glove expectation	What the facility must additionally verify
Nonsterile compounding (USP <795>)	Gloves are required for compounding activities. Sterile gloves are not universally required by this chapter.	Hygiene, glove suitability, changed tasks, glove integrity, contamination prevention, chemistry and applicable hazardous-drug overlay.
Sterile compounding (USP <797>)	Sterile, powder-free gloves with aseptic donning and routine application of sterile 70% IPA as specified.	Sterile packaging and expiration, proper size, glove alcohol compatibility, cuff interface, aseptic competency and activity-specific change rules.
Hazardous-drug compounding (USP <800>)	Two pairs of ASTM D6978-tested chemotherapy gloves for compounding sterile and nonsterile hazardous drugs.	Drug-specific permeation data, powder-free status, gown-cuff configuration, change interval, contamination events and hazardous-waste doffing.
Sterile hazardous-drug compounding (<797> + <800>)	Combine sterile-compounding glove requirements with double chemotherapy-glove protection.	Sterility where required, drug-specific permeation, isolator/CACI glove configuration and contamination-safe transfer and removal.
ISO-classified cleanroom (ISO 14644)	No single glove model is mandated by room classification alone.	Consumable assessment, operator gowning program, process contamination controls and use in the qualified environment.
EU GMP aseptic manufacturing (Annex 1)	Grade/operation-specific sterile protective garments and gloves for critical aseptic activities.	Facility contamination control strategy (CCS), glove integrity and disinfection, qualification and appropriate monitoring.

USP chapters apply by scope and jurisdiction; state pharmacy boards and local policies may impose additional obligations. The formal governing documents are USP <795>, USP <797> and USP <800>.

Material selection

Nitrile, neoprene, latex and vinyl are not interchangeable barriers.

Glove material	Useful characteristics	Limitations and selection gates
Nitrile	Latex-free polymer; widely available in cleanroom and sterile formats; useful combination of dexterity and selected chemical resistance.	Permeation is formulation- and drug-specific. Nitrile is not automatically chemo-tested or solvent-proof; verify accelerators, cleanliness and package.
Neoprene (polychloroprene)	Latex-free alternative used in selected sterile and medical glove applications; can offer different comfort/chemical profiles.	Requires the same drug-specific testing, sterile status, fit and formulation review as nitrile.
Natural rubber latex	Elastic fit and tactile sensitivity can be advantageous for some tasks.	Natural rubber latex proteins may cause Type I allergy; powdered latex is a separate additional concern. Assess manufacturer warnings and user allergies.
Vinyl (PVC)	May be used for selected low-risk, short-duration tasks.	Often weaker for critical dexterity and hazardous-drug protection; do not use as a shortcut for ASTM D6978-confirmed performance.
Butyl / specialty chemical gloves	Potentially appropriate for some aggressive chemicals when properly tested.	Can sacrifice dexterity; may not be supplied sterile or processed/packaged for critical cleanrooms. Select from chemical breakthrough data.
Isolator / gauntlet assemblies	Fixed glove/sleeve barrier engineered for specific containment equipment.	Not interchangeable with disposable hand gloves; require glove assembly compatibility, installation and integrity testing under equipment SOPs.

Choose by specific formulation and test evidence, not material family alone. “Latex-free” does not guarantee freedom from all chemical accelerators; “accelerator-free” is a separate manufacturer attribute.

Read the data sheet

Eight glove specifications buyers regularly misunderstand.

Claim / measurement	What it establishes	What it does NOT establish
Sterile / gamma-irradiated	Manufacturer-stated sterile product and sterilization process for a specified SKU/package.	Chemo resistance, surface cleanliness, no endotoxin or continued sterility after damaged packaging.
ISO 4 / ISO 5 / Class 10 / Class 100	Manufacturer positioning of a glove for a particular cleanroom-use context.	An independent ISO certification of the glove or approval of every process.
Powder-free	No intentionally added donning powder under the relevant product claim.	Low particles, low ionic residues, sterile status or drug resistance.
AQL for holes	Statistical acceptance/quality data according to a defined sampling and test method.	Absolute zero pinholes or a guarantee that every individual glove is defect-free.
Mil / mm thickness	Thickness of the specified location and product construction.	Universal protection across chemicals; thicker is not always chemically superior.
ASTM D6978 tested	Evidence of resistance to permeation under a standardized chemotherapy-drug testing protocol.	Protection against all drugs, all formulations, every solvent, every exposure mode or unlimited wear.
EN ISO 374 chemical marking	Chemical/permeation performance under specific European test and classification methods.	Automatic equivalence to chemotherapy-specific ASTM D6978 results.
Sterile pair-packed / bulk packed	How gloves are packaged and presented to an operator.	A guarantee of correct aseptic presentation, permitted transfer or no glove contact contamination.

For chemotherapy glove procurement, ASTM D6978-05(2023) is the relevant published resistance-assessment practice. Always request the tested-drug permeation table for the exact glove model, including breakthrough data and any special limitation.

Nonsterile preparations

USP795 control contact, cross-contamination and hand hygiene.

The revised nonsterile compounding chapter requires gloves during compounding. For many nonhazardous CNSP operations, a properly selected nonsterile exam glove can be suitable; sterility is not imposed universally simply because the task is pharmacy compounding. ASHP's USP; changes summary specifically notes the updated glove requirement.

Dispensing format

Manage boxed gloves correctly

Keep clean dispensers in designated areas; avoid handling other gloves while extracting a pair and never bring dirty outer packaging into controlled workspaces.

Cross-contact

Change between incompatible tasks

Define change points between preparations, raw components, cleaning, waste handling and environmental contact. Gloves are not a substitute for cleaning equipment.

Chemicals

Identify sensitizers and solvents

Choose the glove after reviewing ingredients, SDS information and task exposure; a general nitrile label does not guarantee protection against every ingredient.

Training

Observe actual technique

Verify hand hygiene before and after use, correct glove removal without touching the contaminated exterior and correct handling of compounded materials.

Important USP <800> overlay

If the nonsterile formulation contains a hazardous drug, <800> controls also apply, including chemotherapy-glove requirements and the required PPE arrangement. A standard nonsterile boxed glove should not be assumed acceptable for hazardous-drug compounding.

Sterile preparations

USP797: sterile gloves are part of aseptic technique, not the whole system.

For sterile compounding, use sterile powder-free gloves donned using an approved aseptic method after appropriate hand hygiene. The revised chapter includes routine application of sterile 70% IPA to gloved hands immediately before compounding and regularly during compounding. The USP797; official FAQ describes situations in which gloves should be re-disinfected, such as handling waste or retrieving materials.

Sterile presentation

Protect the package-to-hand transfer

Confirm expiration, barrier integrity and sterile pair/wallet presentation. Follow the approved entry and aseptic donning sequence; sterile gloves can be contaminated immediately if handled incorrectly.

Hand hygiene

Clean and dry hands first

Gloves do not replace the required hand-hygiene method. Dry hands completely before donning; avoid touching critical glove surfaces with unprotected hands.

Sterile alcohol

Disinfect when indicated

Apply sterile 70% IPA using the approved technique and allow it to dry. Verify repeated-IPA compatibility with the glove supplier and facility process.

During work

Monitor breaches and glove condition

Replace gloves when compromised, contaminated in a way that cannot be acceptably addressed, or when required by the facility SOP; avoid treating alcohol as a repair for tears.

Cleanroom processing, ISO-class marketing and powder-free construction are separate from sterile status. A glove described as “Class 100 / ISO 5” is not necessarily sterile.

Hazardous drugs

USP800: two tested glove layers, verified drug protection and controlled removal.

USP <800> is concerned with hazardous-drug exposure to people and the environment. The USP <800> FAQs updated January 21, 2026 state that two pairs of chemotherapy gloves tested to ASTM D6978 are required when compounding hazardous drugs, whether the preparation is sterile or nonsterile. Gloves must be powder-free and suitable for the hazards in the operation.

Double-gloving is a controlled barrier system.

Inner glove

Create the first protection layer

During hazardous-drug compounding, the inner chemotherapy glove interfaces with the hand and gown as required by the approved gowning configuration.

Outer glove

Provide a replaceable contamination barrier

The outer chemotherapy glove is generally worn over the gown cuff; use procedure-specific sequencing and avoid transferring drug contamination onto clean surfaces.

Drug permeation

Review the actual drug test table

ASTM D6978 testing is not an unlimited-use claim. Look at permeation data for relevant drugs and solvents, then set change intervals and exposure precautions.

Waste and exit

Doff without spreading residue

Follow the designated hazardous-drug doffing sequence and disposal requirements. Do not re-use disposable hazardous-drug PPE.

Contamination event

Treat suspected contact as a change trigger

Visible splash, puncture, suspected drug contamination, or a glove failure can require immediate controlled removal and replacement.

Prevent transfer

Keep exterior and interior controls separate

Clean-glove tasks and high-contact drug surfaces should not share a glove protocol simply because both tasks happen inside the same room.

Change frequency is not just a timer

NIOSH notes that commonly accepted hazardous-drug practice generally limits glove wear to no more than 30 minutes, with earlier changes for damage or suspected contamination. The actual SOP must consider manufacturer permeation data and the drug/task. See NIOSH Managing Hazardous Drug Exposures.

Where requirements overlap

Sterile and hazardous compounding: satisfy both frameworks simultaneously.

Example workflow	Essential glove decision	Special attention
Nonhazardous sterile CSP	Sterile powder-free glove consistent with <797>.	Aseptic donning, sterile 70% IPA routine, cuff fit and integrity.
Nonsterile hazardous-drug compound	Two powder-free chemotherapy-tested glove pairs for HD compounding.	No assumption that a regular lab glove offers tested drug resistance; manage waste and gown interface.
Sterile hazardous-drug CSP	Sterile-compounding requirements plus the hazardous-drug two-glove system.	Confirm sterile glove layer(s) as required by the configuration; select tested gloves appropriate for the actual drugs.
Sterile HD use in CACI	Two ASTM D6978 glove layers remain required; the CACI design determines how layers are arranged.	USP FAQ describes one glove on the sleeve assembly and one over it for the CACI; some facilities use an additional hand glove.
Non-HD sterile transfer into a PEC	Sterile, powder-free gloving plus approved material-transfer and alcohol-disinfection steps.	Do not assume physical entry into an ISO 5 zone alone establishes glove sterility.

A chemotherapy label and sterile label are different attributes. For example, Ansell TouchNTuff 93-700 is described in its manufacturer technical data sheet as sterile and tested per ASTM D6978, but exact drug-specific chemical resistance and the approved gloving configuration still need review.

Chemical resistance

Read permeation data, not just “chemical resistant” on the product page.

Permeation is molecular passage through an intact glove; penetration is passage through holes, tears or seams; degradation is a physical or chemical change in the glove material. Each is a separate failure mechanism. All three matter when a glove is exposed to active ingredients, diluents, disinfectants or cleaning solvents.

Question for supplier	Why it matters	Evidence to request
Was this exact glove tested against the relevant drug?	Performance can vary by active ingredient and glove formulation.	Drug-specific ASTM D6978 permeation results; manufacturer instructions and limitations.
What concentration and solvent were tested?	The formulation may change permeation behavior.	Test solution, concentration, temperature, exposure duration and limitations.
Can the glove tolerate repeated sterile 70% IPA wiping?	Routine sterile compounding includes repeated glove disinfection.	Written manufacturer compatibility and facility assessment of glove integrity after the planned wipes.
What is the mechanical burden?	Stretch, abrasion, pinching and double donning can undermine a barrier.	Fit trial and mechanical evaluation during the actual simulated task.
What happens after contamination?	Disinfection does not necessarily remove or neutralize hazardous-drug residue.	HD deactivation/decontamination SOP, discard procedure, and compatible replacement stock.

Do not use a generic solvent compatibility chart as evidence for every chemotherapy drug. Ask the manufacturer for product-specific permeation information and apply any documented exceptions.

Fit & ergonomics

A glove that is too tight or too loose can undermine protection and technique.

Measure the dominant hand around the widest part of the palm beneath the knuckles, excluding the thumb, and compare with the specific manufacturer/model chart. Check hand length where the supplier uses it. Sizes are not perfectly interchangeable between suppliers or even between glove families. See our detailed SOScleanroom Glove Sizing Chart and Ansell measurement instructions.

Fingertips

No long loose folds

Extra fingertip material can reduce fine control when manipulating stoppers, syringes and connectors; excessively tight fingers can strain or tear.

Palm

No excessive stretch or slipping

The glove should follow the hand without restrictive tension, ballooning, sliding or creasing that impedes precision work.

Thumb & webbing

Full range of controlled movement

Make a gentle pinch, grasp a small item and perform the real motion. No pulling or tight webbing should occur.

Wrist & cuff

Maintain the required garment interface

Verify cuff length and that the cuff does not roll, expose sleeves or create an opening during reaching and full arm movement.

Double-gloving

Fit must work as two layers

Test inner and outer sizes together; squeezing two tight gloves can reduce dexterity and increase user fatigue.

Work practice

Confirm during simulated tasks

Document grip with wet or dry hands, relevant instruments, cleaning motions and ability to remove gloves without touching contaminated exteriors.

Practical six-point fit check

Before approving a new glove: inspect fingertip length, palm tension, thumb flexion, finger webbing, cuff coverage and real-task dexterity. Use operator trials rather than approving a glove by nominal size alone.

Technique at the glove-to-gown boundary

Train the sequence, protect the cuff and prevent contamination during glove changes.

Stage the correct glove

Confirm approved SKU, size, sterile status if needed, package integrity, labeling and expiration.

Perform hand hygiene

Use the procedure appropriate to the facility and allow hands to dry before donning.

Don gowning in approved order

Position sleeves and cuffs before gloving. Garbing sequence is determined by facility SOP, task and regulatory framework.

Don without touching critical exterior surfaces

Use approved aseptic technique for sterile compounding; avoid contamination from packaging, skin and nearby surfaces.

Secure the correct cuff interface

For hazardous-drug double gloves, follow the inner-under/outer-over gown cuff arrangement specified in the controlled SOP.

Verify fit and integrity

Check full hand movement, exposed skin, tears, rolled cuffs and product handling capability before starting.

Use sterile 70% IPA as required

For <797> work, disinfect gloved hands under the facility SOP and allow them to dry. Alcohol does not restore damaged sterility barriers.

Doff without cross-contact

Remove outer/inner layers in the required sequence, prevent exterior contact with skin or clean surfaces, discard correctly and perform hand hygiene.

The original page suggested that glove cuffs must always be over lab-coat cuffs in every situation. That is too absolute. The cuff configuration depends on the operation: double-gloving for hazardous drugs commonly places the inner pair under the gown cuff and the outer pair over it. Document the correct interface for each task.

When to change gloves

A repeatable change protocol protects more than an arbitrary interval.

Trigger	Nonsterile routine activity	Sterile compounding	Hazardous-drug compounding
Visible tear / puncture / loss of fit	Stop, remove and replace.	Stop, follow aseptic recovery procedure, replace.	Stop, manage contaminated gloves under HD SOP and replace.
Contact with contaminated/unclean surface	Change when task/SOP indicates; perform hygiene.	Use the required sterile 70% IPA procedure where appropriate or change if unable to restore acceptable handling status.	Treat suspected drug contamination as HD SOP trigger; disinfection is not a substitute for exposure control.
Moving to different product/task	Define task-boundary changes.	Prevent contact with unqualified items and uncontrolled surfaces.	Maintain separation of drug-contaminated and clean tasks; change as the assessment requires.
Time-based change	Facility hazard assessment and manufacturer guidance.	Use facility SOP; no universal <797> 30-minute glove replacement rule.	NIOSH generally cites no more than 30 minutes; earlier based on damage/drug-specific results.
Leaving a controlled area / PPE doffing	Follow exit/hand hygiene procedure.	Maintain sterile/aseptic gowning and entry controls when re-entering.	Remove and dispose of HD PPE as required; do not re-use disposable HD PPE.

Create a short glove-change decision tree at the workstation: damaged? contaminated? wrong task? timed interval reached? leaving area? Follow the SOP result and record unusual events when quality or exposure risk is involved.

Failure modes

Recognize the difference between a comfort problem and a control failure.

Observed problem	Potential contributing factors	Evaluation / response
Fingertips catch on instruments	Oversizing, extra material or wrong glove shape.	Trial alternative size or model; verify dexterity and aseptic movements.
Gloves tear during donning	Undersizing, fingernails, jewelry, cuff technique, aged stock.	Check sizing, donning training, package aging, and manufacturer defect controls.
Cuffs roll down	Insufficient length, poor fit, sleeve/outer-layer friction.	Evaluate longer cuff and gown interface through movement simulation.
Gloves feel tacky or degrade with IPA	Material formulation or repeated disinfectant contact.	Request manufacturer written alcohol compatibility; qualify change cadence.
Operator develops dermatitis	Irritation, wet hands, frequent hygiene, latex or accelerator sensitivity.	Escalate to occupational health; assess alternative qualified glove products and hand care.
Unexpected particle or residue finding	Packaging, glove surface, wipe chemistry, transfer handling, technique.	Review lot/specification, material cleanliness, handling and environmental trends.
HD glove worn beyond safe exposure	Inadequate scheduling, wrong drug compatibility, incomplete supplies.	Update HD risk assessment, stock and SOP; train on contamination-related early changes.
Failed gloved-fingertip sampling	Aseptic donning, glove disinfection, contact behavior or procedure deviation.	Investigate per <797> personnel qualification and quality requirements; document corrective action.

Isolator and CACI glove systems

Disposable gloves do not replace the glove/sleeve assembly integrity program.

Closed isolators, CAIs, CACIs and other barrier systems use fixed glove assemblies or sleeves that perform a separate containment function from disposable gloves. The equipment manufacturer and process SOP determine installed glove type, leak testing, replacement and operator interface. For hazardous sterile compounding, check the USP800 CACI FAQ for the described two-pair glove arrangement.

Equipment-specific

Glove assembly integrity

Define visual checks, leak or integrity tests, installation and response to failure under the equipment procedure.

Sterile handling

Protect critical-contact surfaces

Select sterile over-gloves and introduce them through approved transfer arrangements; avoid opening unqualified packages in the critical space.

Hazardous containment

Prevent cross-boundary transfer

Define where potentially contaminated external layers are removed and how to protect clean zones and personnel.

Chemical compatibility

Check fixed and disposable barriers

Evaluate disinfectants, sporicides and HD products against assembly glove materials, not solely the disposable over-glove.

Supplier and process qualification

Build a defendable, document-controlled glove approval file.

Step 01

Identify work and risks

List the exact operation, contamination threats, sterile status and chemical/HD exposure. Include double-glove or isolator configuration.

Step 02

Specify performance

Set necessary material, powder-free status, sterility, tested chemotherapy-drug resistance, cuff length, sizes and performance criteria.

Step 03

Review manufacturer evidence

Obtain current TDS, instructions, test documentation, lot certificates where relevant, sterile/expiry documentation and permeation results.

Step 04

Evaluate samples

Perform clean task simulation, fit checks and glove-to-gown interface checks; qualify the actual SKU/size/pack rather than a brand family.

Step 05

Verify process compatibility

Test or document planned IPA exposure, cleaning chemicals, aseptic technique, gowning and critical-manipulation suitability as appropriate.

Step 06

Control inventory and changes

Approve part number and alternates in writing, document minimum remaining shelf life, stock buffers, change control and incident investigation.

Step 07

Train and monitor

Qualify personnel, maintain training/observation records, trend defects and investigate deviations, failed fingertip sampling or contamination events.

Step 08

Reassess on changes

Review substitutions, formulation changes, process modifications, new chemicals, glove reactions or changes in regulatory guidance.

Supplier certificates are evidence about the stated product and lot; they do not independently certify a facility to USP requirements. Validation and acceptance belong to the responsible pharmacy, organization and quality system.

Verified catalog examples

SOScleanroom glove families for engineering and pharmacy review.

The following links were checked against live SOScleanroom listings on October 27, 2026. They are candidate products, not declarations of USP compliance, FDA approval for a particular drug, or interchangeable substitutes. Compare the precise glove SKU, size, sterile presentation, manufacturer documentation and applicable testing before qualification.

Nonsterile exam

Kimtech Polaris Nitrile Exam Gloves

Boxed exam glove example for approved nonsterile tasks; verify the facility workflow and chemical exposures.

Nonsterile chemical splash

Ansell TouchNTuff 92-600

Powder-free nitrile, nonsterile; the SOS listing explicitly says not chemotherapy-drug tested. Not a sterile or HD-compounding recommendation.

Nonsterile cleanroom

Ansell Nitrilite 93-311

Cleanroom nitrile example for nonsterile controlled environments; an ISO label does not convey sterility.

Nonsterile cleanroom

Ansell Microflex CE5-755

Cleanroom glove candidate when particles, handling, packaging and fit matter; check actual SKU documentation.

Sterile aseptic

Ansell BioClean Excell BEXS

Sterile hand-specific nitrile; evaluate aseptic presentation and detailed specifications.

Sterile / chemo-tested candidate

Ansell TouchNTuff 93-700

Manufacturer data sheet reports sterile gamma processing and ASTM D6978 chemo testing; confirm exact drugs and glove-layer scheme.

Sterile pair-packed candidate

TechNiGlove STN200P series

Sterile 12-inch pair-packed nitrile with published D6978 positioning; obtain manufacturer drug permeation documentation before HD use.

Explore the broader Sterile Nitrile Gloves category, Cleanroom Gloves category, Ansell collection and Kimtech gloves. Stock, prices, pack quantities and supplier availability can change; use the live listing when placing an order.

Technical purchasing

What to put in an RFQ or approved-substitution request.

RFQ data field	Minimum useful detail
Application and regulations	Nonsterile CSP, sterile CSP, HD compounded product, cleanroom support or isolator use; identify governing chapter and local SOP.
Exact product identity	Manufacturer, model/SKU, size, material, cuff length, pack presentation and full case unit.
Sterile requirements	Sterile status and process, package integrity, expiration, lot records and applicable documentation.
Hazardous-drug protection	ASTM D6978 testing, drug-specific permeation data, particular drugs and formulations handled, double-glove/over-glove plan.
Cleanroom performance	Surface particle/residue controls, manufacturing and packaging claims, compatible chemical agents, and test-method details.
Operator needs	Fit, sizes by employee population, right/left pair or ambidextrous use, grip, allergy/accelerator concern.
Continuity	Consumption by size, reorder frequency, acceptable remaining shelf life, lead time, alternate approvals and lot-change communications.
Documents	TDS, SDS when appropriate, sterilization/COC/COA records when supplied, current standards and controlled change notifications.

Simplify repeat purchasing

Standardize only after the glove has passed both technical qualification and operator trials. A lower-cost or alternate glove that requires requalification, increased changes or produces more tears may be a higher-cost decision overall.

Standards in context

ISO cleanroom classes and EU GMP Grade A–D are not glove approvals.

ISO 14644-1 classifies airborne particles; ISO 14644-2 addresses the monitoring plan; ISO 14644-5:2025 concerns cleanroom operations; and ISO 14644-18:2023 provides a consumable-suitability assessment framework. None of those automatically establishes sterility or chemotherapy resistance for a specific glove.

EU GMP Annex 1 is a sterile pharmaceutical-manufacturing framework, not a substitute for pharmacy USP chapters. Its contamination-control strategy, aseptic gowning and glove integrity expectations can inform cross-industry practice where applicable. The European Commission Annex 1 source should be consulted for the specific manufacturing application.

For standardized hazard protection, compare published data under ASTM D6978, EN ISO 374 and relevant product specifications. Never infer that an AQL or ISO class rating replaces chemical permeation testing or an effective aseptic gowning procedure.

Real work scenarios

Use these scenarios in staff education and SOP reviews.

Scenario A

Routine nonhazardous cream

A <795> compounder uses an approved powder-free, nonsterile glove. Define when to change after raw-material handling, cleaning and task transitions.

Scenario B

Sterile IV admixture

A <797> operator dons sterile gloves, respects the approved cuff configuration and uses sterile 70% IPA per the compounding SOP. Damaged gloves must be replaced.

Scenario C

Sterile antineoplastic preparation

Apply both <797> and <800>: sterile handling plus two appropriately tested chemotherapy-glove layers, controlled doffing and drug-specific change limits.

Scenario D

Chemical cleaning in support room

Do not automatically use the same glove as in the sterile PEC. Evaluate the cleaner, splash exposure, glove chemical resistance and room/packaging rules.

Scenario E

New glove substitution

Changing the brand or model can alter fit, cleanliness, packaging, chemical protection and glove performance with IPA. Qualify and document before release.

Scenario F

Employee with skin sensitivity

Occupational health and quality should review allergies, chemical accelerators, hand hygiene and alternative glove suitability. Never silently substitute a lower-protection glove.

Primary sources

Official USP, NIOSH, ASTM, ISO and manufacturer guidance.

Publisher / source	What it supports
USP <795> chapter	Scope and minimum framework for pharmaceutical nonsterile compounding; consult the applicable official subscription text.
ASHP — USP <795> key changes	Implementation-oriented summary confirming glove requirement for all nonsterile compounding activities.
USP <797> chapter	Official scope for sterile compounding; consult current effective text and local adoption.
USP <797> FAQ (Dec 2023)	Practical sterile-glove IPA application and compounding-workflow interpretation.
USP <800> chapter	Hazardous-drug handling scope and framework.
USP <800> FAQs (Jan 2026)	Double chemotherapy-gloving for HD compounding and CACI PPE arrangement.
NIOSH Managing Hazardous Drug Exposures	Task-dependent chemical exposure, glove selection, permeability and generally accepted glove change guidance.
CDC PPE-Info — ASTM D6978-05(2023)	Scope of chemotherapy-drug permeation assessment.
Ansell TouchNTuff 93-700 Data Sheet	Manufacturer example of sterile nitrile construction with ASTM D6978 testing statement.
Ansell — How to Measure	Hand circumference and length guidance for glove sizing.
EU Commission — GMP Annex 1	Sterile pharmaceutical manufacturing and contamination control strategy.
ISO 14644-18:2023	Framework for assessing cleanroom consumables, not glove certification.

The full text of certain USP, ASTM and ISO publications may require a license. This page summarizes publicly available publisher information and specific cited supporting material; confirm chapter status, jurisdiction and manufacturer revisions before implementing a controlled program.

Frequently asked questions

Practical answers for compounding staff and purchasing teams.

Does USP795 require gloves for nonsterile compounding?

Yes. The revised USP <795> requires gloves for all compounding activities. Selection should still address ingredient exposure, hygiene, contamination risk and any hazardous-drug overlay.

Do USP795 gloves have to be sterile?

Not universally. Sterile glove use depends on the particular task and other applicable requirements; routine nonsterile compounding can use suitable nonsterile gloves under controlled procedures.

Does USP797require sterile gloves?

Yes, sterile powder-free gloves are part of the aseptic compounding program. Proper hand hygiene, sterile presentation, disinfection and fit also matter.

Do I need chemotherapy gloves for every sterile compound?

No. Sterility and hazardous-drug resistance address different hazards. Determine whether the compounded drug is hazardous and apply the corresponding <800> controls.

Are two glove pairs mandatory during hazardous-drug compounding?

USP <800> FAQs state two ASTM D6978-tested chemotherapy glove pairs are required during compounding of sterile and nonsterile hazardous drugs.

Can one sterile glove be enough in a CACI?

Not for HD compounding when two chemotherapy glove layers are required. The appropriate arrangement depends on the CACI and USP <800> FAQ; consult the equipment-specific SOP.

Does ASTM D6978 mean the glove is safe for all chemotherapy drugs?

No. It is a permeation test protocol. The manufacturer's drug-specific result, formulation and exposure conditions must be evaluated.

How often should chemotherapy gloves be changed?

NIOSH describes generally accepted practice of no more than 30 minutes, and earlier for damage or known/suspected contamination. Use the applicable SOP and drug-specific evidence.

Must every USP797 glove be changed at 30 minutes?

No universal 30-minute glove change is stated here for non-HD sterile compounding. Follow the facility's defined change triggers, integrity checks and any applicable additional requirements.

Can sterile 70% IPA decontaminate a torn glove?

No. Disinfecting an intact glove cannot restore a physically compromised barrier. Replace damaged gloves under the applicable procedure.

Are “Class 100” nitrile gloves automatically sterile?

No. Room-class compatibility and sterile status are separate claims; verify the exact SKU and sterile packaging documentation.

How is nitrile different from latex?

Nitrile contains no natural rubber latex proteins. Actual dexterity, accelerator sensitivity, particles and chemical resistance vary by product, so compare manufacturer data.

Are double-gloves always one size larger?

No. Fit depends on both glove models and the individual. Trial the exact inner/outer combination to ensure safe manipulation and cuff coverage.

Does a glove cuff always go over the gown cuff?

Not in every configuration. Hazardous-drug double-gloving often uses an inner glove beneath and an outer glove over the gown cuff; follow the qualified SOP.

Does a cleanroom glove require ESD properties?

Only when an electrostatic-control assessment requires them. ESD suitability is independent of sterility and chemotherapy resistance.

Can I substitute another nitrile glove in a validated process?

Do not assume interchangeability. New products may differ in sterile status, particles, permeation, IPA response, fit and packaging; use approved change control.

What paperwork should be requested for a sterile glove?

At minimum confirm the correct SKU and size, manufacturer TDS, sterility and packaging information, lot/expiry and any required sterilization or conformity records.

How can SOScleanroom support a glove program?

Provide the intended application, approximate monthly usage by size, approved SKUs, sterility, drug testing and documentation needs when requesting a quote. SOS can identify candidate catalog options without replacing customer quality approval.

SOSCLEANROOM | GLOVE STANDARDIZATION & B2B SOURCING

Select Gloves With Documentation, Not Guesswork.

Share your sterile/nonsterile workflow, hazardous-drug exposure requirements, exact glove models, sizes, annual usage, chemistry, pack format and document needs. We can help you compare candidate products, preserve approved SKU continuity and discuss recurring purchasing programs—while your pharmacy, engineering and quality team retains responsibility for qualification.

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Need assistance? 800-443-7101

Educational and compliance scope: Reviewed October 27, 2026. This is a technical educational resource and procurement selection aid, not legal advice, a substitute for the licensed USP–NF text, an employee safety determination, a medication compounding SOP, a warranty of chemical protection or product certification. Local regulations, current authoritative editions, the specific hazardous drugs and formulations, manufacturer documentation and the facility quality system govern final selection, training, testing and release. Product availability, packaging and published performance may change.