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Kimberly-Clark Kimtech (11821) Pure G3 Sterile Sterling Nitrile Gloves (Size 6)

$464.29
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SKU:
11821
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10 Bags of 30 Pairs (300 Pairs)
Kimtech™ Pure G3 Sterile STERLING™ Nitrile Cleanroom Gloves (SKU 11821, Size 6) — Sterile, Hand-Specific, Silicone-Free Nitrile for ISO Class 3+ Environments
Sterile (SAL 10-6) Nitrile (latex-free) ISO Class 3+ use 12" length 4.0 mil class (finger 3.9 mil nominal) AQL 1.5 Silicone-free

Kimtech™ Pure G3 Sterile STERLING™ nitrile gloves are engineered for sterile, residue-sensitive work where the glove must protect the technician while also minimizing contamination contribution to the process. This hand-specific, gamma-irradiated nitrile design is positioned for ISO Class 3 and higher cleanrooms and is packaged to support aseptic donning and controlled transfer into critical zones.

For operators who need “latex-like” tactile feedback without natural rubber latex, this thin-gauge nitrile platform balances dexterity and tear resistance, with published cleanliness and endotoxin limits to support risk-based contamination control strategies.


Where these gloves fit best
  • Aseptic processing and sterile handling where sterile PPE transfer, packaging integrity, and lot traceability are part of the contamination control strategy (CCS).
  • Sterile compounding, cleanroom pharmacies, and controlled environments where double-don capability and consistent donning discipline reduce excursions.
  • Medical device and life science workflows where technicians need tactile sensitivity for fine manipulation and repeatable grip on tools, components, and packaging.
  • Clean manufacturing steps where published particle and endotoxin limits help teams plan qualification, set incoming inspection expectations, and standardize glove selection by zone.

Key performance and contamination-control drivers
  • Sterilized by gamma irradiation and validated to a Sterility Assurance Level (SAL) of 10-6 per ANSI/AAMI/ISO 11137.
  • Hand-specific geometry with a beaded cuff and textured palm / palm-side fingertips to support controlled handling and reduce slip events during wet work.
  • Silicone-free, powder-free, latex-free nitrile polymer (Acrylonitrile Butadiene) to reduce hidden residue variables in sensitive processes.
  • Published cleanliness limits (particles and endotoxin) to support qualification conversations and audit-ready documentation packages.
  • Packaged for aseptic donning (pair walleted/pouched) and configured for clean transfer: 30 pairs per double bag, 10 double bags per case (300 pairs per case).

Specifications (Size 6 / SKU 11821)
Brand / series Kimtech™ Pure G3 Sterile STERLING™
Material Synthetic nitrile polymer (Acrylonitrile Butadiene); contains no natural rubber latex; silicone-free
Color Sterling (gray)
Size 6
Length 305 mm / 12" nominal
Nominal thickness Middle finger: 0.10 mm (3.90 mil)  |  Palm: 0.08 mm (3.10 mil)  |  Cuff: 0.07 mm (2.80 mil)
AQL (freedom from holes) 1.5 (ASTM D5151; sampling by attributes per ISO 2859-1)
Sterilization Gamma irradiation; validated SAL 10-6 per ANSI/AAMI/ISO 11137
Design details Hand-specific; beaded cuff; textured palm and palm-side fingertips
Packaging configuration 1 pair / poly pouch; 30 pairs / double bag; 10 double bags / case (300 pairs / case)

Note: Glove selection should be matched to your validated process needs (chemical contact profile, task duration, sterilization transfer method, and zone classification). If your application requires specific breakthrough data or permeation performance, incorporate the manufacturer’s technical packet into your documented risk assessment.


Published cleanliness limits (for CCS / qualification planning)
Metric Published limit Method reference (as published)
Particles (maximum) 1200 particles/cm2 ≥ 0.5 µm IEST-RP-CC005
Endotoxin (maximum) 20 EU/pair LAL kinetic turbidimetric method (as published)

In practice, most contamination control programs use these published limits to set incoming qualification expectations, then rely on lot documentation (COA/COI, labels, and packaging integrity checks) as part of ongoing control.


EU GMP Annex 1 alignment notes (operator-focused)

EU GMP Annex 1 emphasizes a risk-based CCS with strong focus on personnel practices, material transfer controls, and documentation discipline. Sterile gloves are not a “checkbox”; they are a controllable variable that can either support your CCS or become a repeating deviation mechanism.

  • Transfer and staging: Keep outer packaging in the less-critical area; remove the outer double bag per your gowning-room flow so only the intended sterile presentation enters the critical zone.
  • Packaging integrity checks: Train technicians to verify seal integrity and expiry before opening. Treat damaged or questionable packaging as nonconforming material.
  • Double-don logic: Use double-don where your CCS calls for it (e.g., aseptic manipulations, frequent contact with hard edges, or tasks with higher tear probability). Replace the outer glove immediately after contact with non-sterile surfaces.
  • Documentation and traceability: Use COA/COI, labeling, and lot coding to support investigations and trend reviews. This is especially valuable when correlating excursions to specific lots, shifts, or workflow steps.

SOP suggestion disclaimer: This guidance is provided as an educational template. Your facility is responsible for validating gowning, disinfection, and glove-change frequencies based on your processes, cleanroom classification, and quality system.


Manufacturer context (Kimtech™ under Ansell stewardship)

Kimtech™ has long been positioned for laboratory and cleanroom consumables where contamination control and worker protection must coexist. In 2024, Ansell completed the acquisition of Kimberly-Clark’s Personal Protective Equipment business, bringing Kimtech™, KleenGuard™, and the RightCycle™ program under the Ansell protection-solutions umbrella. For cleanrooms, that matters because glove performance is only half the story — continuity of supply, documentation consistency, and change management discipline are what keep validated processes stable over time.

SOSCleanroom’s philosophy is straightforward: critical environments cannot be compromised. We prioritize best-in-class PPE programs that support audit-ready documentation, repeatable technician practice, and reliable availability for scheduled production and compounding.



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Last updated: January 10, 2026
 
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