Cleanroom TN100PFB Series 9.5" Nitrile Gloves (Technipak)

Description
Technical Vault

TechNiGlove TechNitrile® TN100PFB Series (TechniPak®) Nitrile Gloves — Class 100 / ISO 5 Protection in a Wipe-Down PVC Dispenser for Controlled Environments

Class 100 / ISO 5 (M3.5) 100% nitrile (latex-free) Powder-free 5 mil 9.5" length Microtextured fingertips TechniPak® PVC dispenser 1000 gloves / case

Product overview

TechNiGlove TN100PFB Series gloves are powder-free, 100% nitrile gloves packaged in the TechniPak® PVC dispenser — a controlled-environment packaging approach intended to reduce the particulate burden associated with traditional paperboard glove boxes. The PVC dispenser can be wiped clean in wet applications, supporting material transfer discipline and point-of-use housekeeping in Class 100 / ISO 5 areas. These 5 mil, 9.5" gloves are puncture-resistant, ambidextrous, and built for operators who need reliable dexterity while controlling contamination risk at the hands.

Why customers choose TN100PFB (TechniPak)

PVC dispenser format is designed to reduce box-sourced particulates versus paper boxes and supports wipe-down at the point of use in wet processes.
Powder-free, 100% nitrile construction helps reduce latex protein exposure concerns while maintaining chemical resistance and toughness.
5 mil thickness provides a durability margin for routine handling, wipe-down support tasks, and tool/fixture contact where puncture risk is real.
Microtextured fingertips improve grip for precision handling and controlled solvent/solution work (as defined by your SOP and chemical compatibility limits).
Published cleanliness metrics (ions, NVR, particles) support qualification discussions when glove residue control is part of the product-contact risk assessment.

Recommended applications

ISO 5 / Class 100 controlled-environment operations where glove boxes must be kept clean at the line (wipe-down PVC dispenser advantage).
Electronics, optics, and precision manufacturing where operator hands are a primary contamination vector and box debris is a known nuisance.
Material handling, staging, and kitting in controlled environments where gloves are frequently accessed and packaging integrity matters.
General cleanroom handling, equipment wipe support, and solution application tasks where nitrile chemical resistance is required (validate to your chemical list).

Note: Sterility is not stated on the product listing for this dispenser format. If your process requires sterile gloves for aseptic manipulations (for example, within ISO 5 critical zones in regulated sterile processing), ensure your gowning program specifies an appropriate sterile glove solution.

Specifications (from published technical data)

Series / format	TN100PFB Series — TechniPak® PVC dispenser (100 gloves per pack)
Cleanroom classification (published)	Class M3.5 (Class 100 / ISO 5)
Material / color	Nitrile / Blue
Powder content	Powder-free
Style / grip	Ambidextrous; microtextured fingertips
Cuff	Beaded
Length	9.5" (240 mm) (published)
Thickness (single wall)	5 mil (0.005") (published)
Tensile strength / elongation	> 12.5 MPa tensile strength; > 500% elongation at break (published)
Typical particle level (published)	>0.5 µm: < 3,000 total particles/cm² (SOS listing; IEST-RP-CC005.2 method) >0.5 µm: < 1,800 total particles/cm² (manufacturer listing; IEST-RP-CC005.4 method)
Typical ion extractables (published)	Fluoride < 0.05 µg/cm²; Chloride < 2.5 µg/cm²; Nitrate < 1.00 µg/cm²; Phosphate < 0.05 µg/cm²; Sulphate < 2.00 µg/cm² (SOS listing) Manufacturer listing (typical targets): Fluoride < 0.05; Chloride < 1.5; Nitrite < 0.05; Nitrate < 1.00; Phosphate < 0.05; Sulphate < 1.00; Bromide < 0.05 (µg/cm²)
Typical NVR (published)	Total NVR (DI water): < 8 µg/cm² (SOS listing) Total NVR (DI water): < 5 µg/cm² (manufacturer listing)
ESD performance (published)	Surface resistivity (in-use): < 1x10⁹ ohm/square per ANSI/ESD SP15.1 (manufacturer listing) Surface resistivity: < 10¹⁰ ohm/sq (SOS listing, ESD-S11.11); static decay: < 0.5 sec (SOS listing, RETS-5-003, 50–60% RH)
Sizes / ordering (published)	XS–XXL (manufacturer listing) Common ordering pattern: TN100PFB (XS), TN101PFB (S), TN102PFB (M), TN103PFB (L), TN104PFB (XL), TN105PFB (XXL)
Packaging (case)	100 gloves per TechniPak®; 10 TechniPaks per case (1,000 gloves/case)
Certifications / documentation (published)	Certificate of Conformance available on request; manufacturer notes production in ISO 9001:2015 and ISO 14001:2015 certified facilities
Country of origin	Malaysia (published in manufacturer certification document)
Sterility	Not stated

Note on published values: cleanliness/ESD metrics can vary by revision, method, and lot reporting format. If ions/NVR/ESD are critical to your risk assessment, request current lot documentation and qualify the glove in your process.

Cleanroom program guidance (U.S. first, global context second)

In U.S.-based cleanroom and regulated manufacturing programs, gloves are treated as a primary contamination control and mix-up risk because they are frequently product-adjacent and constantly in motion. Build glove selection into your contamination control strategy: controlled dispenser placement, consistent sizing, defined change frequency, disciplined donning/doffing, and clear rules for when gloves contact non-clean surfaces (keyboards, carts, door hardware, and cardboard).

For ISO classification language and room discipline, ISO 14644 terminology is commonly used in the U.S. alongside internal quality systems and risk-based controls. Where applicable, align glove box management with material transfer expectations: wipe-down before entry, segregated storage, and clear line-of-sight controls to reduce packaging-derived contamination.

As a secondary/global benchmark, EU GMP Annex 1 reinforces CCS (contamination control strategy) thinking: documented handling discipline, packaging control during transfer, and investigation-ready traceability. Use it as a continuous improvement lens where it fits your business, without treating it as a U.S. legal requirement.

Helpful standards and guidance hubs (for program reference): https://www.iso.org/standard/53394.html | https://www.fda.gov | https://www.astm.org | https://www.iest.org

Build a best-in-class ISO 5 consumables set

SOSCleanroom does not compromise on glove quality for critical environments. A glove program performs best when the full consumables set is aligned to the same cleanliness intent — gloves, wipers, swabs, and approved solutions — so operators can maintain repeatable technique without improvising materials at the point of use.

Texwipe pairing suggestions (ISO 5-aligned wiping and precision cleaning)

For over 35 years, SOS and Texwipe have been close partners, and SOSCleanroom is the authorized Master Distributor of ITW Texwipe for the United States market. For ISO Class 5 wiping, many customers standardize on Texwipe AlphaWipe® TX1009/TX1009B polyester wipers for general cleaning and spill control, where a low-linting wipe is required (note: no wiper is truly lint-free).

Wipers (manufacturer reference): https://www.texwipe.com/alphawipe-tx1009b

Swabs (precision cleaning in controlled environments; validate to your SOP and product-contact risk): https://www.soscleanroom.com/product/swabs/texwipe-tx714a-large-alpha-polyester-cleanroom-swab/

About TechNiGlove and SOSCleanroom supply confidence

TechNiGlove focuses on disposable glove solutions for contamination-controlled work environments, with product lines designed around cleanliness metrics, packaging discipline, and performance consistency. The TN100PFB TechniPak® approach is a packaging-forward solution: reducing paperboard exposure at the dispenser and enabling wipe-down, which is a practical advantage when box debris becomes a recurring source of particles in sensitive areas.

SOSCleanroom supports customers who need dependable cleanroom consumables with fast shipping, excellent customer service, fair pricing, and continuity of supply backed by decades serving controlled environments. If a glove is part of your product-contact risk control, build it into your qualification approach: request current CoC/cleanliness documentation, set change frequency rules, and train to the handling discipline that keeps ISO 5 areas stable.

Documentation

SOSCleanroom product page: TN100PFB Series (TechniPak) — SOSCleanroom

Manufacturer product page: TN100PFB Series (Class 100) — TechNiGlove

Manufacturer Product Spec (PDF): tn100-tnt1200_FRONT.pdf

Manufacturer Certification Info (PDF) — dated May 13, 2025: TechniGlove-130525-TN100PFB.pdf

Chemical resistance / compatibility (PDF): TechNiGlove Chemical Resistance Chart

Alternate chemical compatibility PDF (SOS hosted): TechNiGlove_Chem.pdf

If you have any questions please email us at Sales@SOSsupply.com or give us a call at (214)340-8574.

If you need additional information please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.

Last updated: January 10, 2026

Non-Sterile Nitrile Gloves in Cleanrooms: Managing High-Touch Risk Without Sterile Assumptions

The Technical Vault By SOSCleanroom

ISO 14644 Personnel Controls Non-Sterile Glove Programs High-Touch Operations Change Frequency Discipline Packaging Control Awareness

Cleanroom TN100PFB Series 9.5 Nitrile Gloves (TechniPak®) — what this glove program is designed to control

Cleanroom TN100PFB Series 9.5 nitrile gloves are non-sterile cleanroom gloves packaged using controlled TechniPak® presentation for use in ISO-controlled environments where sterility is not required, but particulate, residue, and handling discipline remain critical. These gloves are commonly selected for assembly, inspection, material handling, and cleaning-adjacent tasks performed outside sterile boundaries.

A frequent cleanroom failure mode is treating non-sterile gloves as “clean enough” to behave like sterile gloves. This assumption leads to extended wear, relaxed change rules, and uncontrolled surface contact. TN100PFB gloves are designed to support controlled cleanroom handling—but only when their non-sterile status is clearly understood and method controls are enforced.

Operations takeaway: Non-sterile cleanroom gloves demand tighter behavioral controls, not looser ones.

ISO-first context: non-sterile does not mean uncontrolled

ISO 14644 focuses on operational discipline, not sterility. Many ISO 5–8 cleanrooms operate legitimately with non-sterile consumables. The risk emerges when glove selection, packaging, and change frequency are not aligned with the contamination sensitivity of the process.

For non-sterile gloves, contamination control relies on handling method, packaging control, and frequency of change. Treating non-sterile gloves as equivalent to sterile gloves introduces uncontrolled bioburden and particulate transfer—especially during high-touch workflows.

Technical reference chart (confirm exact values via product page + manufacturer documentation)

Product family	Cleanroom TN100PFB Series
Material	Nitrile
Thickness class	9.5 mil class (refer to product page)
Packaging	TechniPak® cleanroom packaging
Sterility	Non-sterile (not sterile; not suitable for sterile field use)

Critical distinction: Non-sterile gloves must never be introduced into sterile workflows or treated as sterile via handling assumptions.

Best-practice use (non-sterile glove programs)

Best practice begins with explicit boundary definition. Non-sterile gloves should be restricted to approved cleanroom zones and tasks. Operators must understand where non-sterile gloves are permitted and where sterile gloves are mandatory. Ambiguity at this boundary is a leading cause of audit findings.

Change frequency should be conservative. Replace gloves after contact with non-controlled surfaces, after leaving the controlled zone, after solvent use, after defined time intervals, and immediately if contamination is suspected. Non-sterile gloves should be changed more frequently than sterile gloves, not less.

Use packaging correctly. TechniPak® packaging supports controlled introduction, but only if bags are opened at point-of-use, gloves are removed one at a time, and partial packs are resealed or discarded per SOP.

Typical cleanroom failures with non-sterile gloves—and how to avoid them

Sterile assumption error: Treating non-sterile gloves as sterile. Prevention: explicit labeling and training.
Extended wear: Gloves worn too long because they “look clean.” Prevention: time- and task-based change rules.
Zone crossover: Non-sterile gloves crossing into sterile areas. Prevention: physical and procedural boundaries.
Improper pack handling: Multiple gloves removed at once. Prevention: point-of-use opening discipline.
Uncontrolled substitutions: Similar-looking gloves swapped without approval. Prevention: locked SKUs in SOPs.

Suggested companion products and technical rationale

Non-sterile glove programs are most effective when paired with tools that minimize direct hand contact and support frequent glove changes without workflow disruption.

Suggested swab: Texwipe TX761 Alpha® Polyester Cleanroom Swab — reduces direct glove contact during precision cleaning tasks.
Suggested wiper: Texwipe TX1010 Vectra® Alpha® 10 Cleanroom Wiper — supports controlled wipe-down with predictable fiber behavior.
Suggested solution: Texwipe TX167 Non-Sterile 70% IPA — commonly used in non-sterile cleaning steps where SOP permits.

Disclaimer

This Technical Vault content is provided as supplemental operational guidance only and does not replace manufacturer instructions, facility SOPs, validation protocols, sterility requirements, or regulatory obligations. Always follow applicable ISO standards and site-specific procedures. Non-sterile products must never be used in sterile fields unless explicitly validated and approved. Refer to current manufacturer documentation for performance, packaging, and material compatibility. Control substitutions and document receiving/lot traceability where required.