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Kimtech Pure M3 Sterile Face Masks with Two Knitted Headbands, Pouch Style

Kimberly-Clark Kimtech M3 Sterile Face Masks with Two Knitted Headbands, Pouch Style

$352.86
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SKU:
62483
Availability:
5 - 7 Business Days
Shipping:
Calculated at Checkout
Sterile:
Yes
Quantity Option (Case):
200 Face Masks

Kimtech™ PURE M3 Sterile Pouch-Style Face Mask — Two Knitted Headbands (SKU 62483) — 7" Individually Packaged (200/Case)

Kimtech™ PURE M3 Sterile Pouch-Style Face Masks (Code 62483) are gamma-irradiated sterile cleanroom masks designed to reduce personnel-sourced particulate and microbe shedding at the face/neck interface. The pouch-style breathing chamber improves comfort and airflow versus traditional pleated masks, while the extended Gap Guard is intended to tuck into the neck area of compatible coveralls, hoods, or lab coats to minimize escape paths for particles. Manufacturer guidance recommends these masks for ISO Class 3 and higher cleanroom environments.

Case configuration: 10 bags of 20 masks (200 masks/case). Each mask is individually packaged (pouch-style).

Specifications:
  • Manufacturer code / SKU: 62483
  • Style: Pouch-style mask with two knitted headbands; individually packaged
  • Size: 7"
  • Color: White
  • Packaging: 20/bag; 10 bags/case; 200/case
  • Sterilization: Gamma irradiated; Sterility Assurance Level (SAL) 10-6
  • Recommended cleanroom use (manufacturer guidance): ISO Class 3 or higher
  • Particle Filtration Efficiency (PFE): 97.2% @ 0.1 micron (ASTM F1215-89)
  • Bacterial Filtration Efficiency (BFE): 96.0% @ 3.0 micron (MIL-M-36954C)
  • Differential pressure (breathability): 1.83 mm H2O @ 8 LPM flow rate (MIL-M-36954C)
  • Nosepiece: Fully enclosed, soft, malleable aluminum
  • Outer facing: Clear polyethylene, apertured film (low-lint film outer layer)
  • Inner facing: BiCoSof™ fabric (PP/PE bicomponent spunbond)
  • Filter media: High-efficiency meltblown polypropylene
  • Construction: Ultrasonic bonding
  • Certificates: Certificates of Irradiation available online at www.kimtech.com/certificates
About the Manufacturer:

Kimtech™ (Kimberly-Clark Professional) develops contamination-control PPE for scientific and controlled-environment applications, including cleanroom apparel and sterile masks. For 62483, manufacturer documentation emphasizes a pouch-style breathing chamber for comfort, a tight seal at the nose bridge, and a Gap Guard design to help reduce escape of particles at the neckline when integrated correctly with other garments.

62483 Key Features:
  • Pouch-style breathing chamber designed to improve airflow and comfort versus pleated masks
  • Two knitted headbands for stable positioning and consistent fit during wear
  • Extended Gap Guard intended to tuck into the neck area of coveralls/hoods/lab coats
  • Fully enclosed, soft malleable nosepiece to support a tight seal at the bridge of the nose
  • Low-lint polyethylene film outer layer and soft inner-facing fabric for comfort
  • Gamma-irradiated sterile to SAL 10-6
Benefits in Controlled Environments:
  • Reduces personnel contamination pathways: Helps limit particles/microbes shed from the mouth and nose into sensitive zones (process- and facility-dependent).
  • Improves gowning integration: Gap Guard supports better neck-area integration when tucked correctly into garment openings.
  • Breathability + filtration balance: Manufacturer-published PFE/BFE results paired with low differential pressure support long-wear comfort.
  • Audit-friendly sterility: Gamma sterilization with certificate availability supports documentation requirements for sterile operations.
Common Applications:
  • ISO-classified cleanrooms where mask use is part of the facility gowning program
  • Pharmaceutical and biotechnology controlled environments (sterile areas and support zones)
  • USP <797> sterile compounding environments where sterile PPE is required by SOP
  • Cleanroom material handling, packaging, and inspection activities where personnel shedding must be minimized
Best-Practice Use (Mask + Gowning Integration):
  • Handle by the packaging and bands: Manufacturer donning posters show holding the mask through the protective packaging and separating headbands before placement to reduce direct contact with mask surfaces.
  • Fit check matters: Pinch the nose wire to seal and inhale/exhale to confirm secure fit.
  • Use Gap Guard correctly: Tuck the Gap Guard into the neck area of compatible garments; for post-hood donning, reach under the hood and pull the Gap Guard inside the hood per the manufacturer poster.
  • Minimize adjustments in the cleanroom: If adjustment is required, follow your facility SOP (e.g., glove change or sanitization step) to avoid transferring contamination.
  • Follow your facility SOP first: Cleanroom operations depend on facility classification, process risk, and regulatory requirements.

Note: A mask is only one element of contamination control. The biggest gains typically come from disciplined, repeatable gowning steps (hand hygiene, correct sequence, and minimizing re-touching).


Manufacturer Datasheet Links (SOS-hosted):
 

SOSCleanroom note: Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has supported cleanrooms with critical supplies and contamination-control expertise. Our distribution track record includes multiple industry recognitions, including 11 Texas Instruments Supplier Excellence Awards.

If you need additional information please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.

Product page updated: Jan. 14, 2026 (SOS Technical Staff)

© 2026 SOS Supply. All rights reserved.

The Technical Vault
By SOSCleanroom
Kimtech PURE M3 Sterile (Gamma) SAL 10-6 Pouch-Style + Gap Guard Two Knitted Headbands ISO Class 3+ (Mfr Guidance) 20/Bag · 10 Bags/Case
62483: sterile pouch-style cleanroom mask designed to reduce personnel contamination pathways — with Gap Guard integration for the neck interface
Why face masks matter in cleanrooms (and why technique beats brand)

In ISO-classified cleanrooms, personnel are often the dominant contamination source. The mask is intended to reduce particles and microbes shed from the mouth and nose, but the larger control lever is technique: correct donning order, minimal re-touching, and correct integration at the hood/neck interface. Kimtech’s 62483 adds a pouch-style breathing chamber for comfort and a Gap Guard extension intended to tuck into the neckline of compatible garments.

ISO first: standards context for gowning and mask selection

ISO 14644-1 defines how cleanrooms are classified by airborne particle concentration. Your ISO class (and your process risk) informs what level of gowning control you need. ISO 14644-5 addresses cleanroom operations via an Operations Control Programme (OCP), explicitly including personnel management and a gowning programme (policies, training, entry/exit discipline, cleaning and monitoring).

Practical takeaway
Masks should be selected and used as part of your facility’s ISO-based gowning programme — not as a standalone purchase decision. The cleanroom class drives how strict your donning sequence, garment integration, and behaviour controls must be.
Annex 1 overlay (Europe / sterile pharma)

If you operate under EU GMP Annex 1 (sterile medicinal products), the expectations become more explicit: contamination control strategy (CCS), cleanroom classification, monitoring, and personnel practices (training, hygiene, gowning qualification). Annex 1 is often applied even beyond strictly sterile products when contamination reduction is critical (site decision + documented rationale).

What this product is (manufacturer-defined)

Kimtech PURE M3 Sterile Pouch-Style Face Mask Code 62483 is a 7" white pouch-style mask with two knitted headbands, a fully enclosed soft malleable aluminum nosepiece, a clear apertured polyethylene outer facing, a soft inner-facing BiCoSof™ fabric, and high-efficiency meltblown polypropylene filter media. Manufacturer documentation states masks are double bagged and gamma irradiated to SAL 10-6.

Packaging: 20/bag, 200/case (10 bags/case). Certificates of Irradiation are available via the manufacturer certificate portal.

Specifications (data-sheet basis)
Attribute 62483 (Published)
PFE @ 0.1 micron 97.2% (ASTM F1215-89)
BFE @ 3.0 micron 96.0% (MIL-M-36954C)
Differential pressure 1.83 mm H2O @ 8 LPM (MIL-M-36954C)
Sterility assurance Gamma irradiated; SAL 10-6
Packaging 20/bag; 10 bags/case; 200/case; individually packaged
Recommended cleanroom use ISO Class 3 or higher (manufacturer guidance)
Cleanroom donning education (mask + hood integration)
Manufacturer donning steps (reduce touch contamination)
  • Open carefully: open protective packaging without contacting the mask surface.
  • Separate headbands: while holding the mask through the packaging, reach in and separate headband straps.
  • Place + secure: pull bands over the head and secure while holding the Gap Guard/packaging to keep the mask in place and reduce contamination.
  • Seal at nose: pinch nose wire into place.
  • Fit check: inhale and exhale to check for secure fit.
  • Hood interface: (a) Pre-hood: put hood on over the mask; (b) Post-hood: reach under the hood and pull the Gap Guard to the inside of the hood.

ISO-based gowning programmes typically emphasize consistent sequencing (so each layer protects the next), minimal re-touching, and correct closure at the hood/neck interface. The Gap Guard feature is only effective if it is consistently tucked/positioned per your SOP and the manufacturer poster guidance.

Common failure modes (what to watch during training)
  • Over-handling the mask surface: handle via packaging and bands; avoid touching filtration surfaces.
  • Poor nose-bridge seal: leads to fogging and leak paths; shape the enclosed nosepiece and confirm fit.
  • Gap Guard left outside the hood/neck closure: creates a direct pathway for shedding toward the garment opening.
  • Adjustments after gowning: repeated re-touching transfers contamination; follow your SOP (often including glove change/sanitization).
  • Training drift across shifts: correct technique must be taught, observed, and periodically requalified (ISO OCP mindset).
Selection notes (what to confirm before qualification)
  • ISO class + process risk: use the facility classification and risk profile to determine sterile vs. non-sterile PPE requirements.
  • Packaging statement: current TDS states double-bagged; legacy sell sheet references triple-bagged. Confirm packaging spec on the latest manufacturer documentation for your receiving requirements.
  • Certificate needs: if your QA programme requires irradiation certificates (or lot traceability expectations), align your receiving checklist with the manufacturer certificate portal.
SOSCleanroom note about SOPs

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 (including ISO and, where applicable, EU GMP Annex 1).

If you adapt any 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 process and acceptance criteria.

Source basis (manufacturer first)
  • SOSCleanroom product page (62483): https://www.soscleanroom.com/product/kimtech/kimberly-clark-kimtech-m3-sterile-face-masks-with-two-knitted-headbands-pouch-style/
  • Manufacturer Technical Data Sheet (Revised Apr 2014): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/pouch%20style/KIMTECH%20PURE%20M3%20Sterile%20Pouch%20Style%20Face%20Mask.pdf
  • Manufacturer Sell Sheet (Effective July 2010): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/M3-Sterile-Mask-Sell%20Sheet.pdf
  • Manufacturer Donning Poster (Pre-Hood): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/pouch%20style/M3-Sterile-%20Mask-Pre-%20Hood-%20Donning-%20Poster.pdf
  • Manufacturer Donning Poster (Post-Hood): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/pouch%20style/M3SterileMaskPostHoodDonningPoster.pdf
  • ISO 14644-1 (classification context): https://www.iso.org/standard/53394.html
  • ISO 14644-5 (operations + gowning programme context): https://www.iso.org/standard/88599.html
  • EU GMP Annex 1 (sterile medicinal products): https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf
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
Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has supported cleanrooms with critical supplies. Our distribution track record includes 11 Texas Instruments Supplier Excellence Awards.
If you need additional information please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.
Last reviewed: Jan. 14, 2026
© 2026 SOSCleanroom