Cleanroom TN2000 Series 12" Nitrile Gloves (Class 100 / ISO Class 5)
Class 100 / ISO Class 5 (M3.5) 12" / 300 mm length Powder-free nitrile No natural rubber latex No silicone ESD properties (published)
Brand: TechNiGlove | SKU: TN200x | Availability: 7 - 10 Business Days | Case unit: 1,000 Gloves Per Case (10 Bags of 100 Gloves)
Overview
Cleanroom TN2000 Series 12" nitrile gloves are TechNiGlove’s Class 100 / ISO Class 5, powder-free, ambidextrous cleanroom gloves built for contamination-controlled work environments that depend on low particle and low extractables performance. TN2000 gloves are 100% nitrile, contain no natural rubber and no silicone, and are offered in multiple colors (white, blue, and green) so teams can color-code by size, process step, or double-gloving logic.
Why this matters in ISO Class 5: In critical environments, gloves are often the highest-contact “tool” in the room. A Class 100 / ISO 5 glove with published cleanliness limits helps reduce operator-driven contamination during assembly, wipe-down, component handling, and metrology work.
About TechNiGlove (manufacturer context customers ask for)
Founded in 1998, TechNiGlove International designs and manufactures disposable cleanroom gloves for contamination-controlled work environments. Their TN2000 Series is positioned for Class 100 / ISO Class 5 operations and is built around documented particle and extractables controls. The manufacturer publishes ordering logic by size and color, and supports batch-specific documentation workflows (including Certificate of Conformance requests).
Packaging, options, and sizing
- Pack: 100 gloves per poly-sealed cleanroom bag
- Case: 10 bags per case (1,000 gloves per case)
- Colors: White, Blue, or Green (site selection)
- Sizes: XSM, SM, MD, LG, XL, 2X
- Batch testing: Exclusive online batch testing is available for this product (documentation-based qualification support)
Glove sizing:
Size 6 to 6.5 = X-Small
Size 7 to 7.5 = Small
Size 8 = Medium
Size 9 = Large
Size 10 = X-Large
Size 10.5 and up = XX-Large
Published specifications (at-a-glance)
| Specification |
Value |
| Cleanroom classification |
Class M3.5 / Class 100 / ISO Class 5 |
| Material |
100% nitrile; powder-free; no natural rubber; no silicone |
| Style |
Ambidextrous |
| Length |
12" (300 mm) |
| Thickness |
5 mil (0.005") |
| Grip surface |
Microtextured fingertips |
| Cuff |
Beaded |
| Mechanical performance (published) |
Tensile strength > 12.5 MPa; elongation at break > 500% |
Cleanliness and extractables (published limits)
These published limits help customers screen glove suitability for ISO Class 5 work. For critical programs, qualify against your internal limits using incoming lot documentation and your site’s validation/qualification plan.
| Metric |
Published value |
Method / context (as stated) |
| Liquid particle levels |
Class M3.5 (100): < 1200 total particles/cm² > 0.5 µm |
IEST-RP-CC005.2 method (as stated on site listing) |
| Typical ionic extractables |
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 |
Published ionic limits |
| Total NVR (DI water) |
< 3.00 µg/cm² |
Published limit |
ESD properties (published)
- Humidity condition: At 50–60% RH (as stated)
- Surface resistivity: < 1010 ohm/square (ESD-S11.11 listed on site) and manufacturer literature commonly references < 1x109 ohm/square (ANSI/ESD SP15.1) for in-use performance
- Static decay: < 0.5 seconds (RETS-5-003 listed on site)
- Certificates: Certificate of Conformance available on request
Operator use guidance for ISO Class 5 work (standards-informed)
U.S. contamination-control programs typically anchor to FDA expectations and facility SOPs; USP <797>/<800> may apply depending on your operation. EU GMP Annex 1 is often used as a secondary/global benchmark to reinforce risk-based CCS thinking, disciplined transfer practices, and documentation rigor without implying Annex 1 is a U.S. legal requirement.
- Donning discipline: Don gloves using controlled motion to reduce particle generation. Avoid snapping open packaging and avoid rubbing gloves against garments.
- Sanitization compatibility: If your process requires frequent glove sanitization (e.g., sterile IPA in ISO 5), confirm compatibility and change-out frequency using your site’s risk assessment and the chemical compatibility chart.
- Change-out triggers: Replace gloves after contacting non-controlled surfaces, after handling aggressive solvents, when you observe tackiness/softening, or at your defined time-based interval.
- Documentation and traceability: Record lot/batch identifiers where required to support deviation investigations and repeatable process control.
Reference points (customer education):
FDA: https://www.fda.gov
ISO (ISO 14644 terminology reference): https://www.iso.org/standard/53394.html
ASTM: https://www.astm.org
IEST: https://www.iest.org
Recommended companion consumables for ISO Class 5 processes
In ISO Class 5 workflows, gloves can be “clean” while the process still fails due to wipe-down and sampling technique. Pairing TN2000 gloves with appropriately clean, low-linting wipers and cleanroom swabs helps reduce recontamination during assembly, transfer, and inspection. Note: no wiper is truly lint free; look for low-linting materials with documented cleanliness.
- Low-linting polyester wipers (ISO 4–5 use common): https://www.soscleanroom.com/product/wipers/texwipe-tx1009-alphawipe-9-x-9-polyester-cleanroom-wiper/
- Sterile wipers (when sterile wiping is required at point-of-use): https://www.soscleanroom.com/product-category/wipers/sterile-wipers/
- Cleanroom swabs for precision cleaning/sampling: https://www.soscleanroom.com/product-category/swabs/
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. Many customers standardize glove + wiper + swab together to support continuity of supply and consistent documentation in contamination-control programs.
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Last updated: January 10, 2026
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