The Technical Vault
By SOSCleanroom
TechNiGlove STN2000B Series 12" Sterile Nitrile Cleanroom Gloves (Bulk Packed) — ISO 5 / Class 100 Sterile Change Discipline for Aseptic, ESD-Sensitive Work
ISO Class 5 / Class 100
Sterile (gamma irradiated)
12" / 300 mm
Bulk packed (100/bag)
ESD properties published
1,000 gloves/case
TechNiGlove STN2000B sterile bulk-packed nitrile cleanroom gloves (blue).
1) Practical solutions in a critical environment
STN2000B is built for ISO Class 5 / Class 100 zones where glove change discipline is a control point, not a convenience. In aseptic processing, compounding support areas, and contamination-controlled electronics work, gloved hands are frequently the highest-touch “tool” in the room. This glove is positioned to reduce background contribution (particles, ions, residue) while staying practical for high-throughput operations that prefer bulk access at point of use.
Important handling note (bulk-sterile reality): These bulk packed sterile gloves are intended to be opened in a sterile cleanroom only.
Standards context: In U.S. programs, contamination control and gowning discipline are typically anchored to FDA cGMP expectations and aseptic processing guidance, plus USP <797>/<800> where applicable. EU GMP Annex 1 is a useful global benchmark for risk-based Contamination Control Strategy (CCS) thinking and continuous improvement, but it is not a U.S. legal requirement. The practical takeaway is universal: control touches, control transfers, and document what matters.
2) What is this glove used for
- Sterile, non-medical cleanroom work requiring ISO 5 discipline (common in USP <797> support workflows and controlled sterile handling steps).
- Aseptic operations where high glove-change frequency is expected and bulk-packed sterile access improves workflow efficiency.
- ESD-sensitive handling programs (electronics/device assembly) when paired with your facility ESD controls, grounding, and verification methods.
- General ISO 5 contamination control tasks: material staging, component handling, wipe-down execution, and controlled transfer activities.
3) Why should customers consider this glove
- ISO 5 / Class 100 alignment: positioned for controlled environments where gloves are a primary contamination vector and must be treated like a validated consumable.
- Sterile bulk-packed workflow: designed for high-throughput change discipline without the pouch-per-pair burden of individually packed formats.
- Published cleanliness limits: particle, ionic extractables, and NVR limits support documentation-driven selection and troubleshooting baselines.
- Microtextured fingertips: grip support for tools, tubing, wipe-down items, and containers during routine aseptic handling.
- ESD properties published: supports programs where static attraction increases particle loading and defect risk.
4) Materials and construction
Material: Nitrile (powder-free). Form factor: 12-inch (300 mm) ambidextrous glove with microtextured fingertips, positioned by the manufacturer for ISO 5 / Class 100 work. The nitrile platform eliminates natural rubber latex proteins and supports many facilities’ allergy-risk and sensitizer-control programs.
In ISO 5 work, glove construction is only half the story. The other half is how the glove is introduced, donned, disinfected (if your SOP permits), and changed. Bulk-packed sterile gloves can be operationally excellent, but only when packaging discipline is treated as part of the contamination control system.
5) Specifications in context
STN2000B is intended for ISO 5 operations where you want a sterile glove plus bulk access (100 gloves per bag) to support frequent changes. If your process requires pair-packed sterile presentation or hand-specific orientation, specify a different sterile packaging format aligned to your SOP and aseptic technique.
| Attribute |
STN2000B (published) |
| Brand / series |
TechNiGlove STN2000B series (SKU shown on SOS: STN200xB) |
| Cleanroom alignment |
Class 100 / ISO Class 5 |
| Material |
Nitrile (powder-free) |
| Length |
12" / 300 mm |
| Surface |
Microtextured fingertips |
| Sterility method (stated) |
Gamma irradiation (manufacturer states sterilized to meet AAMI and ASTM standards) |
| Packaging (bulk packed) |
100 gloves/bag; 10 bags/case (1,000 gloves/case) |
| Color (SOS listing) |
Blue |
| ESD properties (stated) |
Published (see cleanliness/ESD section) |
| Country of origin (certificate example) |
Malaysia (example certificate) |
6) Cleanliness metrics
The tables below summarize manufacturer-published limits and an example certificate dataset. Use them as a baseline for risk assessment and investigation work (trending, background contribution, deviation review). Your actual results depend on operator technique, glove-change timing, disinfectant compatibility, and the way packaging is introduced into the room.
Particles (limit)
| Metric |
Published value |
| Particles (≥ 0.5 µm) |
< 800 particles/cm² (stated as “Class M3.5 (100)” on manufacturer spec page) |
Typical ion extractables (upper limits, µg/cm²)
| Ion |
Published upper limit |
| Fluoride | < 0.01 |
| Chloride | < 0.15 |
| Nitrate | < 0.17 |
| Sulfate | < 0.23 |
| Phosphate | < 0.02 |
| Sodium | < 0.14 |
| Ammonium | < 0.07 |
| Potassium | < 0.03 |
| Magnesium | < 0.002 |
| Calcium | < 0.01 |
NVR (upper limit)
| Metric |
Published value |
| Total NVR (DI water) |
< 3 µg/cm² |
ESD control (published)
| Metric |
Published value |
| Surface resistivity (in use) |
1 × 109 ohms/sq (ANSI/ESD SP15.1 stated by manufacturer) |
| Certificate example (ohms/sq) |
Example CoC dataset shows values in the ~1010 ohms/sq range (lot-specific; verify your shipment’s certificate) |
7) Packaging, sterility, and traceability
- Sterility approach (stated): gamma irradiation; manufacturer states sterilized to meet AAMI and ASTM standards.
- Bulk packed format: 100 gloves per bag; 10 bags per case (1,000 gloves per case). Bulk packed sterile product requires strict point-of-use discipline to protect sterile intent.
- Lot traceability: manufacturer provides a certificate of conformance example that includes cleanliness and ESD data; verify your lot’s certificate for your quality records.
- Quality systems (stated by manufacturer): ISO 9001:2015 and ISO 14001:2015 certified facilities.
Transfer discipline reminder: treat the outer packaging as a transfer item, follow your facility wipe-down/material transfer rules, and open inner packaging only inside the controlled area at the point of use.
8) Best-practice use (operator-level)
The biggest ISO 5 glove failures are rarely “bad gloves.” They are technique drift, transfer shortcuts, and change frequency that does not match the risk.
- Define a glove-change trigger set: time-based (interval), event-based (touching non-sterile surfaces), and task-based (post-cleaning, post-transfer, post-contact with waste stream). Write it down and enforce it.
- Bulk-pack opening discipline: open only in the sterile cleanroom; do not stage open bags “for convenience.” Minimize exposure time and reseal/cover per your SOP if the workflow permits.
- Double-gloving logic: for higher-risk steps, use a clean underglove with an outer glove changed more frequently. Color-coding can help with compliance when permitted by your program.
- Glove disinfection: if your SOP allows, use approved sterile alcohol wipes or sprays with defined contact time and wetness control. Do not “wipe until dry” without defined method; that increases variability.
- ESD program alignment: gloves alone do not “solve” ESD. Verify grounding, worksurface resistance, and process limits; treat glove resistivity as one component in a controlled system.
- Pair the glove with the right wiping system: in ISO 5 zones, use low-linting, sealed-edge sterile wipers and sterile swabs for detail work. No wiper is truly “zero-lint” across every surface condition and operator method, so selection plus technique controls matter.
ISO 5 matching suggestions (Texwipe): If your process environment is ISO Class 5 and requires sterile wiping/swabbing support, consider pairing STN2000B with:
- Texwipe TX3224 Sterile TexTra10 9" x 9" polyester cleanroom wiper (sterile, sealed border; listed for ISO 3–8 including ISO 5): https://www.soscleanroom.com/product/wipers/texwipe-tx3224-sterile-textra10-9-x-9-polyester-cleanroom-wiper/
- Texwipe TX3285 Sterile AlphaSat 10 (sterile pre-wetted 70% IPA system positioned for ISO 3–5 and isolator/BSC interiors): https://www.soscleanroom.com/categories/wipers/pre-wetted-wipers/sterile/sterile-alphasat-10/
- Texwipe STX763 sterile polyester swab (individually wrapped, lot/expiration marked; gamma irradiated SAL 10-6 is stated on the SOS Technical Vault entry): https://www.soscleanroom.com/product/swabs/texwipe-stx763-sterile-gamma-irradiated-polyester-swab/
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. That matters when your CCS depends on stable consumables, consistent documentation, and continuity of supply.
9) Common failure modes
- Bulk-pack sterility compromise: opening outside the sterile area, staging open bags, or repeated exposure with no defined control.
- Under-changing gloves: “one pair, many tasks” creates uncontrolled transfer and is a common root cause in investigations.
- Over-wet glove disinfection: excessive IPA without method control can drive dripping, residue lines, and unpredictable recontamination when hands touch surfaces.
- ESD assumptions: relying on glove resistivity alone without verifying grounding and worksurface compliance.
- Compatibility blind spots: not qualifying glove compatibility with disinfectants, chemotherapeutic drugs, or process solvents when those contacts are part of the work.
10) Closest competitors
When comparing sterile nitrile gloves for ISO 5 work, focus on: (1) packaging format and how it fits your sterile presentation method, (2) published cleanliness/ESD metrics, (3) documentation set (CoC/irradiation/lot marking), and (4) change-discipline economics that do not incentivize “over-wear.”
- Ansell 93-700 TouchNTuff Sterile Disposable Nitrile Cleanroom Gloves (Class 100 / ISO 5; gamma irradiation SAL 10-6 is stated on the SOS product page): https://www.soscleanroom.com/product/brands/ansell-93-700-touchntuff-sterile-disposable-nitrile-cleanroom-gloves-class-100-iso-5/
- Kimtech Pure* G3 sterile STERLING* nitrile gloves (sterile nitrile program with published data pack and donning/SOP support): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/G3%20Sterile%20Sterling/Sterile/G3%20Sterile%20STERLING%20Nitrile%20Gloves%20Data%20Pack%207-20-2017.pdf
11) Critical environment fit for this glove
STN2000B fits ISO 5 programs that want sterile intent plus a bulk-packed operational rhythm. This is especially relevant where glove changes are frequent (routine manipulations, repeated material touches, repeated wipe-down cycles) and where operators need predictable dexterity with microtextured grip.
If your CCS calls for stricter sterile presentation (pair-packed, individually packed, or hand-specific orientation) or if your quality system requires a different documentation set, select a sterile glove and packaging format that aligns to those controls.
SOSCleanroom program note: In critical environments, the glove is only half the control. The other half is supply continuity and documentation discipline. SOSCleanroom supports contamination-control programs with responsive technical support, fast shipping, and a stable sourcing path so methods do not drift due to substitutions when re-qualification is expensive.
12) SOSCleanroom note about SOP's
The Technical Vault is written to help customers make informed contamination-control decisions and improve day-to-day handling technique. It is not your facility’s Standard Operating Procedure (SOP), batch record, or validation protocol.
Customers are responsible for establishing, training, and enforcing SOPs that fit their specific risks, products, equipment, cleanroom classification, and regulatory obligations. Always confirm material compatibility, cleanliness suitability, sterility requirements, and acceptance criteria using your internal quality system and documented methods.
If you adapt any technique guidance from this entry, treat it as a starting template. Your team should review and approve the final method, then qualify it for your specific surfaces, solvents, cleanliness limits, inspection methods, and risk profile. In short: use these best-practice suggestions to strengthen your SOPs—not to replace them.
13) Source basis
Product + manufacturer documentation
- SOSCleanroom product page (STN2000B): https://www.soscleanroom.com/product/apparel/cleanroom-stn2000b-series-12-sterile-nitrile-gloves-bulk-packed/
- Manufacturer product page (STN2000B specifications): https://www.techniglove.com/product/stn2000b/
- Certificate of conformance example (cleanliness/ESD data; lot-specific): https://www.techniglove.com/wp-content/uploads/2026/01/TechniGlove-200525-TN2000B.pdf
- Product spec sheet front (series overview; manufacturer PDF): https://www.techniglove.com/wp-content/uploads/2026/01/stn200-stn1000-stn2000_FRONT.pdf
- Chemical resistance chart (SOS-hosted PDF): https://www.soscleanroom.com/content/Gloves/TechNiGlove_Chem.pdf
Standards and regulatory references (customer education)
- ISO (cleanroom standards reference page): https://www.iso.org/standard/53394.html
- FDA: https://www.fda.gov/
- ASTM: https://www.astm.org/
- IEST: https://www.iest.org/
SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
If you have any questions please email us at Sales@SOSsupply.com or give us a call at (214)340-8574.
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Last reviewed: Jan. 10, 2026
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