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Cleanroom STN2000B Series 12" Sterile Nitrile Gloves (Bulk Packed)

Cleanroom STN2000B Series 12" Sterile Nitrile Gloves (Bulk Packed)

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STN200xB
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TechNiGlove STN2000B Series 12" Sterile Nitrile Cleanroom Gloves (Bulk Packed) — Class 100 / ISO 5, Low-Particle, ESD-Controlled Handling
Class 100 / ISO 5 Sterile (gamma irradiated) Nitrile Powder-free Ambidextrous Microtextured fingertips 12" (300 mm) length Bulk packed Blue ESD properties published 1,000 gloves / case
Product overview
TechNiGlove STN2000B is a sterile, bulk-packed 12" blue nitrile glove built for Class 100 / ISO Class 5 contamination-controlled work where glove change discipline, low particle contribution, and predictable operator handling matter. This ambidextrous design is sterilized by gamma irradiation and is commonly specified for USP <797> workflows and other sterile non-medical cleanroom activities where a sterile glove is required but bulk economics and fast point-of-use access are preferred.
Important handling note: These bulk packed sterile gloves are intended to be opened in a sterile cleanroom only.
Why customers choose STN2000B
  • ISO 5 / Class 100 alignment: Designed for low-particle controlled environments where gloves are a primary product-contact and contamination-control risk.
  • Sterile, cost-efficient workflow: Bulk-packed sterile format supports high-change-frequency programs while maintaining sterile presentation discipline at the point of use.
  • Microtextured fingertips: Helps operators maintain grip on tools, tubing, wipe-down items, and containers during routine aseptic handling steps.
  • Nitrile comfort and broad utility: Nitrile is widely selected where puncture resistance and intermittent-contact splash protection are required (always verify chemical compatibility for your exact exposure).
  • Traceability support: Case/batch marking is positioned to support internal QC requirements and investigation readiness.
Recommended applications
  • ISO 5 / Class 100 cleanroom operations requiring sterile glove use (sterile non-medical environments)
  • USP <797> compounding workflows where sterile gloves are part of the aseptic technique program
  • Aseptic set-ups, sterile material staging, and clean transfers in critical zones
  • Routine handling of components, fixtures, and tools where low particle contribution is prioritized
  • Controlled cleaning steps where sterile gloves are specified as part of the line-clearance or environmental discipline
For chemotherapy/hazardous drug programs, confirm that glove performance and documentation align with your internal requirements, including any testing expectations and change frequency rules.
Specifications (from published technical data)
SOSCleanroom SKU (series) STN200xB (size-dependent)
Cleanroom classification Class M3.5 / Class 100 / ISO Class 5
Material / color Nitrile / Blue
Style Ambidextrous
Powder content Powder-free
Grip surface Microtextured fingertips
Cuff Beaded
Glove length 12" (300 mm)
Thickness (published) 5 mil (0.005")
Tensile strength (published) > 12.5 MPa
Elongation at break (published) > 500%
Particle levels (published method) Class M3.5 (Class 100): published limits include < 800 total particles/cm² > 0.5 µm (IEST-RP-CC005.2 method).
Note: Some legacy listings may show < 1,200; use lot documentation for acceptance criteria.
Typical ion extractables (published limits) Fluoride < 0.01 µg/cm²
Chloride < 0.30 µg/cm²
Nitrite < 0.01 µg/cm²
Bromide < 0.05 µg/cm²
Nitrate < 0.30 µg/cm²
Phosphate < 0.01 µg/cm²
Sulphate < 0.05 µg/cm²
Total NVR (DI water, published limit) < 3.00 µg/cm²
ESD properties (published) Surface resistivity (in use): 1 x 109 ohms/square per ANSI/ESD SP15.1 (published).
Additional published listings include surface resistivity < 1010 ohm/square at 50–60% RH; static decay ≤ 0.5 seconds; tribo charge ≤ 20 V (verify on lot documentation).
Sterility Sterile; sterilized by gamma irradiation (published)
Available sizes (SOS selection) XSM, SM, MD, LG, XL, 2X
Packaging (case) 100 gloves per bag; 10 bags per case (1,000 gloves per case)
Certificates (published availability) Certificate of Conformance: available on request
Certificate of Sterility: available on request
Country of origin (published) Malaysia
Always validate glove selection and use in your process: chemical exposure profile, product-contact risk, sterile presentation method, glove change frequency, and any qualification documentation required by QA/QC.
Cleanroom program guidance (U.S. first, global context second)
In U.S.-based cleanrooms and regulated operations, gloves are treated as a primary contamination control and mix-up risk because they touch product, tools, and critical surfaces. For ISO 5 spaces and USP <797> programs, results depend on the basics: controlled donning/doffing, defined glove change triggers, sterile presentation discipline, and strong line-of-sight accountability at the point of use. ISO 14644 terminology is commonly used in the U.S. alongside internal quality systems and FDA-oriented risk thinking (especially where aseptic processing concepts apply).
As a secondary/global benchmark, EU GMP Annex 1 reinforces risk-based contamination control strategy (CCS) thinking: defined interventions, glove integrity/change discipline at critical steps, material transfer controls, and documentation that supports investigation readiness. 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
Customers standardize on ISO 5 gloves like STN2000B to control the highest-risk contact point in the room: the operator. To reduce overall contamination risk, match sterile gloves with ISO 5-aligned wiping and swabbing materials that control particles and residues during cleaning, line clearance, and routine handling.
About TechNiGlove and SOSCleanroom supply confidence
Founded in 1998 by Roger W. Gass, TechNiGlove International has positioned itself as a specialist in disposable gloves for contamination-controlled work environments. In ISO 5 and sterile workflows, consistency matters: formulation control, clean processing, sterile presentation discipline, and access to documentation that supports qualification and ongoing control.
SOSCleanroom supports customers who need dependable, best-in-class cleanroom consumables with fast shipping, excellent customer service, fair pricing, and continuity of supply backed by decades serving controlled environments. When your program depends on repeatability, substitutions and documentation gaps create avoidable risk—we work to help customers stay standardized and audit-ready.
Documentation
Manufacturer product page (specifications): TechNiGlove STN2000B (Class 100)
Certificate of Conformance example (includes cleanliness/ESD data): TechniGlove-200525-TN2000B.pdf
Product spec sheet (series front sheet): stn200-stn1000-stn2000_FRONT.pdf
Chemical resistance chart (quick reference): 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
© 2026 SOSCleanroom.com
The Technical Vault
By SOSCleanroom
TechNiGlove Cleanroom STN2000B Series 12" Sterile Nitrile Cleanroom Gloves — ISO 5 / Class 100 (M3.5), Bulk Packed (100/bag), Blue, ESD Properties Listed
ISO 5 / Class 100 (M3.5) Sterile (Gamma Irradiated) Bulk Packed (100/bag) 12" / 300 mm 5 mil Nitrile • Powder-Free Microtextured Fingertips 1,000 Gloves/Case
1. Practical solutions in a critical environment

STN2000B is built for ISO 5 / Class 100 zones where glove change discipline is a control point, not a convenience. In aseptic handling, compounding support areas, and contamination-controlled electronics/device work, gloved hands are often the highest-touch “tool” in the room. This glove is positioned to reduce background contribution (particles, ions, and residue) while staying practical for high-throughput operations that prefer bulk access at point of use.

Important handling note (bulk-sterile reality): Bulk packed sterile gloves should be introduced and opened only inside the controlled area at point of use, following your facility transfer and aseptic technique rules.

2. What this glove is for
  • ISO 5 / Class 100 work where sterile gloves are required, but bulk economics and rapid change-outs are preferred.
  • USP <797> workflows and other sterile non-medical cleanroom activities where sterile presentation is defined by SOP.
  • Material staging, clean transfers, and routine handling of components where low particle contribution is prioritized.
  • ESD-sensitive handling programs when paired with your facility ESD controls, grounding, and verification methods.
3. Selection rationale
  • ISO 5 alignment: Positioned for controlled environments where gloves are a primary contamination vector and must be treated like a qualified consumable.
  • Sterile bulk workflow: Bulk packed sterile format supports high change frequency without the pouch-per-pair burden of individually packed formats.
  • Cleanliness limits for troubleshooting: Particle, ionic extractables, and NVR limits help set baselines for investigations and process trending.
  • Microtextured fingertips: Supports grip on tools, tubing, wipe-down items, and containers during routine aseptic handling.
  • ESD properties listed: Useful where static attraction can increase particle loading and defect risk.
  • Traceability readiness: Case/batch marking supports internal QC requirements and investigation documentation.
SOSCleanroom selection philosophy
SOSCleanroom supports customers who need dependable, best-in-class cleanroom consumables. In critical environments, we do not recommend “good enough” substitutes when process risk, product integrity, and compliance expectations are on the line.
4. Materials and construction
  • Material: Nitrile
  • Color: Blue
  • Shape: Ambidextrous
  • Cuff: Beaded
  • External surface: Microtextured fingertips
  • Internal surface: Smooth nitrile interior (controlled donning with correct technique)
  • Powder content: Powder-free
5. Specifications in context

In ISO 5 operations, glove specs are operational controls. Bulk-packed sterile gloves can be an excellent system choice, but only when packaging discipline is treated as part of the contamination control strategy: transfer correctly, open at point of use, and define change-out triggers that match the risk.

Specification Value Operational meaning
Cleanroom class Class M3.5 / Class 100 / ISO Class 5 Aligns to critical-zone expectations where glove handling discipline directly affects outcomes.
Sterility Sterile; gamma irradiation Supports sterile handling when your SOP requires sterile gloves; protect sterile intent with correct transfer and opening discipline.
Freedom from holes AQL not listed on the product page (request lot documentation if needed) If AQL is part of your qualification, retain the certificate package for the lots you are approving.
Length 12" / 300 mm Supports gown-to-glove overlap and reduces exposed interface risk during reaching and rotations.
Thickness targets 5 mil (0.005") Work-glove durability for frequent manipulations while preserving tactile control for aseptic handling.
Tensile (before aging) > 12.5 MPa Durability indicator tied to stretch behavior during donning and intervention work.
Elongation at break (before aging) > 500% Higher elongation helps reduce tear events when operators need controlled stretch at the cuff and fingers.
Tested for chemotherapy drugs Listed as suitable for chemotherapy applications For hazardous drug programs, confirm your drug list, breakthrough criteria, and change frequency rules per your PPE program.
Anti-static / ESD ESD properties listed (see Section 6) Confirm alignment to your facility ESD method and controls (grounding, ionization, verification cadence).
Country of origin Not listed on the product page (retain certificate package if required) Needed for some sourcing/QA programs; retain documentation when qualifying lots.
Shelf life Confirm via case labeling and certificates per lot Rotate inventory and verify expiry/lot at point-of-use per SOP.
6. Cleanliness metrics

For ISO 5 work, “sterile” does not automatically mean “low-background.” Particle release, ionic extractables, and NVR are the three metrics most often tied to real-world deviations (visible particulate, unexpected film/residue, or sensitivity in analytical/assembly processes). Use the values below as baselines, and retain lot documentation for your qualification file.

Metric Value Method / reference
Particle level (≥ 0.5 µm) < 800 total particles/cm² IEST-RP-CC005 method (Class M3.5 context)
Typical ion extractables (examples) Fluoride < 0.01 µg/cm²; Chloride < 0.30 µg/cm²; Nitrate < 0.30 µg/cm²; Sulphate < 0.05 µg/cm² Manufacturer technical data / certificate package (lot-specific)
Total NVR (DI water) < 3.00 µg/cm² Manufacturer technical data / certificate package
ESD surface resistivity (in use) 1 × 109 ohms/sq ANSI/ESD SP15.1 (facility verification recommended)

Practical note: Background control is as much technique as it is glove selection. Avoid cuff snapping, fast dry rubbing on packaging, and staging opened bulk bags. Tie glove change-outs to time-in-zone, interventions, wipe-down cycles, and suspect-contact events.

7. Packaging, sterility, and traceability
  • Case configuration: 100 gloves/bag; 10 bags/case; 1,000 gloves/case
  • Sterilization method: Gamma irradiation (AAMI/ASTM alignment noted by manufacturer)
  • Available sizes: XSM, SM, MD, LG, XL, 2X
  • Shelf life: Confirm via case labeling and certificate package per lot
8. Best-practice use
Customer SOP disclaimer
This guidance is provided as a suggested starting point for customer SOP development and operator training. Every cleanroom and process is different. Customers must evaluate risk, validate procedures, and obtain appropriate QA/ES approval before implementation. Always follow your facility gowning and aseptic technique requirements and the manufacturer’s instructions for use.
  • Stage with intent: Bring bulk sterile packaging into the room per SOP and open only at point of use. Do not stage opened bags for “later.”
  • Donning without particle events: Control cuff opening (no snapping), don slowly, and avoid dry rubbing gloves on packaging or garments.
  • Sanitization (facility-defined): If glove sanitization is part of your program, use sterile alcohol and define reapplication triggers and wet-contact expectations in the SOP.
  • Double-donning: Often used when intervention steps or frequent wipe-downs increase tear risk. Define inner/outer roles and change cadence.
  • Change-out triggers: Treat any tear, puncture, cuff roll-down, residue buildup, or contact with non-qualified surfaces as an immediate change-out event.
Suggested pairings: wipers, swabs, and solutions for sterile glove workflows
In ISO 5 work, glove performance is only part of the outcome. Consistency improves when teams standardize the “glove + wiping + detailing + solution” set so operators are not improvising at point-of-use.
Use case Recommended item Why it pairs well
ISO 5 critical wipe-downs (equipment, benches, transfer items) Texwipe TX3224 Sterile TexTra10™ 9" x 9" Polyester Cleanroom Wiper Sterile, low-lint polyester wiper supports repeatable wipe patterns and controlled solvent delivery in critical zones.
Sterile gowning room wipe-downs and aseptic support areas Texwipe TX8932S Sterile TexVantage™ 12" x 12" Cellulose/Polyester Cleanroom Wiper Sterile larger-format wiper supports faster coverage on carts and staging areas while maintaining contamination-control discipline.
Detail cleaning (ports, fittings, interfaces, corners) Texwipe STX763 Sterile Gamma-Irradiated Polyester Swab Sterile swab for controlled solvent cleaning in tight geometries where wipers cannot maintain contact.
Sterile IPA delivery (routine spray application) Texwipe TX8270 Sterile 70% Isopropanol Alcohol Solution (8 oz) Sterile, ready-to-use spray format helps standardize application volume and pattern for routine wipe-down steps.
Sterile IPA bulk use (high consumption points) Texwipe TX3290 Sterile 70% Isopropanol Alcohol Solution (1 Gallon, 4/Case) Bulk sterile IPA supports high-use points; align dispensing controls to avoid over-wetting and reduce rework from streaking or residue movement.
Guardrail: Confirm solution compatibility with your surfaces and your facility SOPs (wet-contact time, reapplication triggers, and glove change-out triggers).
9. Common failure modes
  • Bulk bag drift: Open bags staged for convenience, gloves exposed longer than necessary, or gloves retrieved with repeated touching.
  • Transfer shortcuts: Outer packaging not treated as a transfer item; inadequate wipe-down or incorrect material entry steps.
  • Tear events at fingertips: Snag points (sharp edges, clips, hardware) plus aggressive handling during interventions.
  • Grip loss during wiping: Over-wetting, residue transfer, or wrong wipe substrate for the soil type.
  • Inconsistent change-outs: Without defined triggers, glove life varies by operator; tie change-outs to interventions, wipe cycles, and suspect-contact events.
10. Other gloves to consider

These alternatives are commonly evaluated in sterile ISO 5 decision sets. Selection should be driven by packaging preference (bulk vs. pair-packed), tactile needs, and the intervention model defined in your facility procedures.

11. Program fit for regulated cleanrooms
  • ISO 5 decision sets: Sterile, low-background glove intended for controlled environments where operator touch is a primary risk lever.
  • Bulk sterile discipline: Strong fit when facilities have clear transfer steps, point-of-use opening rules, and defined glove change triggers.
  • Documentation-driven programs: Best fit for teams that retain lot/expiry documentation and certificate packages for qualification and investigations.
  • ESD-sensitive handling: Useful where static attraction is a known defect driver; confirm performance with your ESD verification approach.
12. Source basis
Product documentation
Standards & guidance references
These references are included to support terminology and program alignment. Customers should confirm applicability to their processes and approved SOPs.
Technical Vault Notice
Important disclaimer: This entry is provided for general process support and reference only. It is not regulatory, legal, medical, or validation advice.
Customers must evaluate risk, confirm applicability to their processes, and follow their approved SOPs, QA requirements, and the manufacturer’s instructions for use.
Questions or documentation requests: Sales@SOSsupply.com  |  (214) 340-8574
Last reviewed: January 30, 2026
© 2026 SOSCleanroom.com