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Cleanroom TN1000 Series 12" Nitrile Gloves (USP 797 & 800)

Cleanroom TN1000 Series 12" Nitrile Gloves (USP 797 & 800)

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SKU:
TN100x
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TechNiGlove TN1000 Series 12" Powder-Free Nitrile Cleanroom Gloves — ISO Class 5 / Class 100, Double-Bagged, ESD-Controlled, USP <797> / USP <800> Support
Nitrile 12" / 300 mm ISO 5 / Class 100 (M3.5) Powder-free Double chlorinated Double-bagged ESD-controlled (surface resistivity) Non-sterile
Overview
TechNiGlove TN1000 Series is a 12" powder-free nitrile cleanroom glove designed for contamination-controlled work where glove cleanliness, consistency, and coverage matter. The TN1000 platform is commonly used in ISO Class 5 / Class 100 (M3.5) environments, with a microtextured fingertip grip and beaded cuff for secure wear during repetitive handling cycles. Double-bagged packaging supports controlled transfer practices in cleanroom and pharmacy workflows.
Why 12" cleanroom gloves are chosen for USP <797> and USP <800> workflows
In real facilities, glove selection is not just about “PPE.” The glove becomes part of the contamination control strategy: it touches primary surfaces, handles critical components, and can be a meaningful source of background if the glove is not controlled for particles, extractables, and handling residues. The 12" length improves wrist/forearm coverage and helps maintain overlap at the gown sleeve interface during compounding and cleaning tasks.
Practical note (how TN1000 is typically used in USP environments)
TN1000 is non-sterile and is commonly qualified as an under-glove in USP <797> workflows when a sterile outer glove is required at point-of-use. For sterile outer glove options, see: STN200P (pair packed) or STN1000W (bulk packed). For USP <800> hazardous drug tasks, the platform is identified as meeting ASTM D6978 chemotherapy requirements (verify your site’s drug list and SOP compatibility).
Key features and benefits
  • Cleanroom classification support: Listed for Class M3.5 / Class 100 / ISO Class 5 use.
  • Controlled contamination profile: Published particle, ionic, and NVR limits support residue-sensitive work and documentation-driven programs.
  • ESD-controlled performance: Surface resistivity and static decay metrics support electronics and handling where electrostatic attraction can increase deposition risk.
  • Coverage + secure wear: 12" length with a beaded cuff helps maintain gown/glove overlap and reduces wrist exposure.
  • Grip where it matters: Microtextured fingertips improve handling control without “over-texturing” the glove surface.
Specifications (quick reference)
Cleanroom classification Class M3.5 / Class 100 / ISO Class 5
Material 100% Nitrile (no natural rubber or silicone)
Sterility Non-sterile
Length 12" (300 mm)
Thickness 5 mil (0.005")
Grip surface / cuff Microtextured fingertips / Beaded cuff
Colors White or Blue
Tensile / elongation >12.5 MPa / >500% (elongation at break)
Particle level (method reference) <3000 total particles/cm² >0.5 µm (IEST-RP-CC005.2 reference)
Ionic limits (surface) Fluoride <0.05, Chloride <3.0, Nitrite <0.05, Nitrate <3.00, Phosphate <0.05, Sulphate <3.00 (µg/cm²)
Total NVR (DI water) <8.00 µg/cm²
ESD performance Surface resistivity <1010 ohm/sq (ESD-S11.11) / Static decay <0.5 sec (RETS-5-003) @ 50–60% RH
Packaging and handling
  • Order unit: Case
  • Case pack: 1,000 gloves per case (10 bags of 100 gloves)
  • Controlled transfer friendly: Double-bagged configuration supports staged entry and cleaner handling disciplines.
  • Chemical compatibility: Reference the TechNiGlove chemical resistance chart for screening guidance: Download 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: Jan. 29, 2026 © 2026 SOS Supply. All rights reserved.
Technical Vault — TechNiGlove TN1000 Series 12" Nitrile (TN100x)
How cleanroom teams and compounding pharmacies typically qualify TN1000: contamination control intent, under-glove strategy, ESD posture, and documentation points that matter during audits.
What TN1000 is (and what it is not)
TN1000 is a non-sterile, powder-free, 12" nitrile cleanroom glove listed for Class M3.5 / Class 100 / ISO Class 5 use. It is typically qualified as a controlled-environment glove for process protection and personnel protection — and in USP settings it is often used as an under-glove when sterile outer gloves are required at point-of-use.
Sterile point-of-use reminder
If your SOP requires sterile gloves at point-of-use (common in ISO 5 primary engineering controls), qualify the sterile outer glove strategy separately. Two common sterile options: STN200P (pair packed) and STN1000W (bulk packed).
USP <797> / USP <800> qualification logic (how teams avoid common misses)
  • Under-glove consistency: Facilities often standardize one under-glove across rooms to control variables (fit, tactile sensitivity, residue background), then qualify sterile outer glove models per workflow.
  • HD handling validation: The product is identified as meeting ASTM D6978 requirements for chemotherapy drug handling; responsible programs still verify compatibility against their drug list, contact time, and change interval policy.
  • Change frequency is a control: The best glove in the world fails if it stays on too long. Define change triggers in SOPs (tear, wetting/soiling, exiting controlled zones, HD contact, disinfectant saturation, etc.).
  • Gown-glove interface: 12" cuffs reduce exposed wrist risk, but only if the sleeve overlap is maintained during motion. Train for “reach” and “twist” moments where sleeves pull back.
Contamination control + ESD posture (why these metrics exist)
TN1000 publishes contamination-related limits (particles, ions, NVR) and ESD performance targets. Those numbers become meaningful when you tie them back to your risk: residue-sensitive assemblies, aseptic touch surfaces, and electrostatic attraction that can increase deposition.
Particles (method reference) <3000 total particles/cm² >0.5 µm (IEST-RP-CC005.2 reference)
Ionic limits (surface) Fluoride <0.05, Chloride <3.0, Nitrite <0.05, Nitrate <3.00, Phosphate <0.05, Sulphate <3.00 (µg/cm²)
Total NVR (DI water) <8.00 µg/cm²
Surface resistivity / static decay <1010 ohm/sq (ESD-S11.11) / <0.5 sec (RETS-5-003) @ 50–60% RH
Chemical resistance — screening tool, not a substitute for SOP validation
Use the chemical resistance chart as a screening reference, then validate against your actual chemicals, concentration, contact time, and exposure pattern (splash vs. immersion). If you handle hazardous drugs, align the chart review with your HD policy and glove change intervals.
Documentation & change control (what auditors usually ask for)
  • Certificate of Conformance: Available on request.
  • Lot traceability: Keep lot/expiry records aligned to your glove program SOP and any HD handling documentation requirements.
  • Spec drift monitoring: If particles/ions/ESD posture are critical to your process, consider periodic incoming verification or supplier documentation review.
  • Training tie-in: Document the “why” behind change triggers and gown-glove overlap. Operator discipline is typically the top driver of glove-related findings.
Questions? Email Sales@SOSsupply.com or call (214) 340-8574. Technical Vault content is educational and intended to support SOP development and qualification. Facilities remain responsible for validation, risk assessment, and compliance decisions. Last updated: Jan. 29, 2026 © 2026 SOS Supply. All rights reserved.