Cleanroom Gloves & Apparel Nitrile, Latex, Polychloroprene Gloves & Cleanroom Garments, Masks, Sleeves, Boots & Hoods Includes ISO-class-by-glove mapping, sterile vs non-sterile guidance, USP <797> / USP <800> notes, chemical compatibility matrix, thickness comparison, and gowning discipline fundamentals. ▼ EXPAND FOR TECHNICAL INFORMATION (click here to open)
Category Overview
Cleanroom Gloves & Apparel
Barrier protection + contamination control for ISO-class environments, sterile compounding, and critical manufacturing
Barrier Integrity Low-Shedding Sterile / Non-Sterile USP <797> / <800>
Cleanroom gloves and apparel are the primary contamination-control barrier between people and product. Selection should match your SOP and risk profile across ISO class, sterility needs, chemical exposure, particle/shedding control, comfort/fit, and documentation/traceability expectations. In many facilities, the correct glove/garment system reduces excursions, improves audit outcomes, and stabilizes yields across shifts.
Best suited for: ISO 4–8 cleanrooms across pharmaceutical/biotech, sterile compounding, medical device, semiconductor/microelectronics, aerospace, optics, and laboratory environments.
What’s included in this category:
- Gloves: cleanroom nitrile, latex, polychloroprene; sterile gloves; extended-cuff options; specialty/chemo-rated where applicable
- Garments: coveralls, frocks/coats, hoods, sleeves, shoe/boot covers, bouffants, beard covers
- Masks: cleanroom masks, sterile masks, specialty masks/neck-guard variants (per facility SOP)
- Accessories: tape/labels (where used for gowning programs), dispensers, and related staging controls (varies by facility)
Aseptic ISO 5 work
→ Sterile gloves + sterile gowning system; consider double-gloving per SOP
General ISO 7–8 production
→ Cleanroom-rated gloves + low-shedding garments matched to airflow/particle goals
Chemical / disinfectant exposure
→ Verify compatibility + thickness; upgrade to chemical/chemo-rated when required
Selection Guide
How to choose the right gloves & apparel system
A best-in-class PPE selection is not “one SKU fits all.” Use this order of operations: (1) ISO class + process criticality, (2) sterility requirement, (3) chemical exposure / disinfectant program, (4) particulate/shedding control, (5) fit + comfort for compliance, (6) traceability expectations. If you need fundamentals, see our Cleanroom 101.
ISO-class-by-glove mapping (directional, SOP-driven)
Use this as a decision shortcut. Final requirements always come from your facility SOP, risk assessment, and quality program (especially in regulated aseptic/compounding).
| ISO class / zone | Typical work | Glove direction | Apparel direction | Notes / triggers |
|---|---|---|---|---|
| ISO 4–5 (critical / aseptic) | Aseptic manipulations, sterile staging, critical fills/compounding, high-risk exposure control | Sterile cleanroom gloves; extended cuff preferred; double-glove when required | Sterile garments/accessories when required; low-shedding full system | Change gloves at defined intervals; disinfect outer glove per SOP; control sterile transfer packaging |
| ISO 6 (clean production) | Assembly, staging, sensitive handling where particle control is tight | Cleanroom-rated nitrile/latex/polychloroprene; sterile if process demands | Coveralls/frocks + hood + boots; mask as required; low-shedding fabrics | Select for particle control + dexterity; use zone segregation and change-out discipline |
| ISO 7 (buffer / production) | Typical pharma/biotech manufacturing support, device assembly, packaging (varies) | Cleanroom-rated gloves; sterile when required by SOP or workflow step | Gowning system matched to shedding risk; masks/hoods/boots per program | Comfort drives compliance—fit, grip, and sweat management matter for real-world control |
| ISO 8 (support / staging) | Material staging, warehouse-to-clean transitions, noncritical prep | Cleanroom or controlled-environment gloves (avoid general-purpose where contamination matters) | Smocks/coats + hair/boot covers as required; focus on traffic + transfer control | Zone labeling + dedicated PPE reduces cross-contamination between areas |
USP-focused guidance (large compounding market)
If you operate sterile compounding or hazardous drug workflows, glove and garb selection is not optional—it is a compliance control. Your SOP should reference the latest official USP chapters and your facility risk assessment.
- USP <797> (sterile compounding): glove disinfection, change frequency, and sterile technique must be enforced; sterile gloves are commonly required for ISO 5 manipulations (per your SOP and program).
- USP <800> (hazardous drugs): requires chemotherapy gloves (powder-free) and emphasizes correct donning/doffing, inspection, and change-out intervals. For sterile compounding of hazardous drugs, facilities often require a sterile outer glove (per SOP).
- Documentation: lot traceability, expiry dating (where applicable), and training records are frequent audit touchpoints.
- Compatibility: disinfectants and HD deactivation agents can stress glove materials—verify compatibility and thickness for your specific chemical set.
Compounding reality check
Even sterile gloves do not remain sterile forever during work. The control is your technique + disinfection + change-out discipline. Build the workflow so glove contact is intentional and surfaces are not casually touched.
Glove material selection + thickness tradeoffs
Material drives barrier behavior, tactile performance, and chemical compatibility. Thickness drives durability and resistance but can reduce dexterity. Always confirm the exact glove spec sheet for thickness (mil) and compliance claims.
| Material | Strengths | Tradeoffs | Typical use | Thickness direction |
|---|---|---|---|---|
| Nitrile | Strong all-around barrier, good puncture resistance, common cleanroom choice | Some solvents can degrade performance; comfort varies by formulation | General cleanroom, pharma/biotech, microelectronics, many disinfectant programs | Thin for dexterity; thicker for durability/chem exposure (verify spec) |
| Latex | Excellent tactile feel and elasticity for precision work (where allowed) | Allergy risk; not preferred in many facilities; chemical compatibility varies | Legacy programs or precision work where facility policy permits | Use the thinnest that still meets barrier needs + SOP (verify) |
| Polychloroprene (Neoprene family) | Often chosen for chemical handling + comfort balance; good elasticity | Not universal—must verify against your specific disinfectants/solvents | Disinfectant-heavy workflows, some compounding programs, extended wear | Medium thickness often preferred; increase for high exposure (verify) |
| Chemo-rated (material varies) | Intended for hazardous drug contact where required; tested per applicable standards | Chemical list matters; breakthrough time differs by drug/solvent and glove | USP <800> HD handling (unpacking, compounding, administration, cleaning) | Often medium-to-thicker; follow manufacturer breakthrough data |
Chemical compatibility matrix (directional — verify with glove permeation data)
This matrix is a practical starting point, not a substitute for manufacturer permeation/breakthrough testing. For regulated programs, document your final selection using glove manufacturer data + your chemical list.
| Chemistry / exposure | Nitrile | Latex | Polychloroprene | Chemo-rated (as labeled) | Practical note |
|---|---|---|---|---|---|
| 70% IPA / ethanol wipe-downs | Good (verify for extended exposure) | Fair–Good (facility-dependent) | Good (verify) | Good | Repeated disinfecting can fatigue gloves—use change-out rules |
| Oxidizers (e.g., peroxide-based disinfectants) | Fair–Good (verify) | Fair (verify) | Fair–Good (verify) | Good (if specified) | Oxidizers can stiffen materials—confirm compatibility + comfort |
| Quats / general disinfectants | Good (verify) | Fair–Good (verify) | Good (verify) | Good | Residue control + glove tackiness can affect handling |
| Sporicides (aggressive programs) | Fair–Good (verify) | Fair (verify) | Good (often chosen; verify) | Good (if specified) | Sporicides can be harsh—thickness + change frequency matter |
| Hazardous drugs / chemo agents | Use only if chemo-rated and documented | Not preferred unless documented and allowed | Use only if chemo-rated and documented | Primary direction | Follow USP <800> PPE requirements + manufacturer breakthrough times |
Important compatibility note
Chemical resistance depends on the exact glove formulation, thickness, temperature, and exposure duration. Always verify against the glove manufacturer’s chemical resistance / permeation data for your specific chemicals and dwell times.
Apparel system essentials (what actually controls people-generated contamination)
- Head-to-toe coverage: hoods, masks, garments, sleeves, and boot covers reduce shedding into airflow and product zones.
- Fabric + design: low-shedding materials and closures that minimize particle escape; avoid gaps at wrists/ankles/neck.
- Fit drives compliance: uncomfortable systems fail in real life—size correctly and choose breathable designs where possible.
- Zone discipline: dedicate PPE by area; label storage; prevent cross-zone reuse and uncontrolled staging.
- Single-use vs reusable: if reusable, laundering and packaging must be validated to prevent cross-contamination.
Best-practice glove & gowning fundamentals (SOP-ready)
- Gown in the correct order: follow your facility sequence to prevent touching exposed skin/hair after clean layers are on.
- Inspect gloves: check cuffs and fingertips; replace immediately if torn, tacky, or degraded.
- Change early: set time/step triggers (not “when it looks dirty”). Change after contact with non-controlled surfaces.
- Disinfect outer gloves: where required, use validated wipes/sprays and respect contact time; avoid oversaturation and dripping.
- Doff without recontamination: remove in a way that keeps contaminated exteriors away from skin and clean apparel.
For the fastest recommendation, be ready to share: ISO class/zone, sterile vs non-sterile requirement, the chemical/disinfectant list (and dwell times), HD/chemo handling (USP <800>), desired cuff length, thickness preference (dexterity vs durability), and whether you use disposable or validated reusable garments.
SOSCleanroom supports cleanroom programs across semiconductor, pharmaceutical, medical device, aerospace, optics, and sterile compounding environments—where PPE selection and discipline directly impact outcomes.
Need help selecting?
Talk to a cleanroom specialist
Email Sales@SOSsupply.com or call (214) 340-8574.
SOSCleanroom Disclaimer
Guidance provided here is directional and must be validated against your facility SOPs, quality system, and current manufacturer documentation. Glove and apparel performance depends on ISO classification, task criticality, chemical exposure, contact time, glove formulation/thickness, fit, operator technique, and change-out discipline. For USP <797> / USP <800> programs, customers are responsible for confirming compliance with the current official chapters and internal policies. Always consult current manufacturer spec sheets, test data, and SDS where applicable. Specifications and availability may change without notice.