SKU shown: 62467 (7" standard, sterile, soft-tie, pleat-style mask).
Why cleanroom masks matter (and why technique matters more)
Cleanrooms are controlled because people are the largest variable. A mask helps reduce droplets and particulates released during breathing and speaking,
but the real contamination-control benefit comes from consistent donning (gowning), disciplined handling, and a complete garment system
(hood/hair cover, coverall or gown, boots, and gloves) governed by an operations control program.
What this product is
Kimtech 62467 is the KIMTECH PURE® M3 sterile pleat-style face mask with soft ties in the 7" (standard) size.
The manufacturer states it is gamma irradiated to a sterility assurance level of 10-6 and supplied double-bagged.
Case configuration for this code is 20 masks per bag and 200 masks per case (10 bags of 20).
The manufacturer also states this mask is recommended for ISO Class 3 and higher cleanroom environments.
Published construction and performance (manufacturer data)
| Attribute |
62467 (Published basis) |
| Style / size |
Pleated; 7" standard; soft ties |
| Sterilization |
Gamma irradiated; SAL 10-6 |
| Packaging |
20/bag; 200/case; double-bagged |
| PFE (post-sterilization) |
89.3% @ 0.1 µm (ASTM F1215-89) |
| BFE (post-sterilization) |
94.1% @ 3.0 µm (MIL-M-36954C) |
| Differential pressure (post-sterilization) |
2.16 mm H2O @ 8 LPM (MIL-M-36954C) |
| Key construction elements |
Fully enclosed malleable aluminum nosepiece; ultrasonic bonding; PE outer; BiCoSof* inner; meltblown polyester filter media; spunlaced polyester ties |
ISO-first: how gowning (donning) reduces contamination
ISO cleanroom classification is commonly referenced through ISO 14644-1 (air cleanliness by particle concentration), but operational control is where facilities win or lose.
ISO 14644-5 (Operations) describes an operations control programme that includes personnel management and a gowning programme.
In practice, that means the best mask is only as good as the gowning sequence that keeps its outside surface from being touched or contaminated.
Donning guidance for soft-tie cleanroom masks (use with your facility SOP)
- Stage the packaging correctly: open the outer bag in the less-clean zone; transfer the inner bag into the cleaner zone before opening (align to your gowning-room flow).
- Handle by ties/edges only: treat the mask face (outside) as a controlled surface—avoid touching it.
- Tie order matters: set the top tie first to position and seal, then secure the bottom tie for stability.
- Form the nosepiece once: shape the enclosed nosepiece to reduce gaps; avoid repeated adjustments after gloving.
- Avoid “mask drift”: if the mask becomes wet, slips, or is repeatedly touched, replace it per SOP.
- Doff safely: remove by the ties; do not pull from the mask face; dispose per facility policy.
EU Annex 1 overlay (when sterile manufacturing expectations apply)
If your operation is aligned to EU GMP Annex 1 (sterile medicinal products), gowning expectations tighten because the contamination-control strategy (CCS),
personnel training/qualification, and behavior controls are treated as direct product-risk controls. Annex 1 emphasizes controlling contamination from personnel
and supporting appropriate cleanroom design, airlocks/change rooms, and disciplined practices. In Annex 1 environments, ensure your mask choice (sterile vs. non-sterile),
transfer method (double-bag handling), and replacement frequency are explicitly defined in your CCS/SOPs and supported by qualification evidence.
Selection notes (62467 vs. close alternatives)
- Soft ties vs. earloops: ties generally enable a more adjustable seal and more stable fit for longer wear; earloops can be faster to don but may vary more by face shape and motion.
- 7" standard vs. 9" large: choose 9" when operators need more coverage or tie geometry for fit; qualify through your comfort/fit and contamination-risk assessment.
- Sterile vs. non-sterile: sterile masks support sterile-area workflows and audit expectations when sterility documentation is required by SOP.
SOSCleanroom continuity note
Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has supported cleanrooms with critical supplies and disciplined documentation expectations.
We maintain long-term relationships across leading cleanroom manufacturers (including Ansell and Kimtech) and have earned multiple distribution awards,
including 11 Texas Instruments Supplier Excellence Awards. That history matters when your program needs steady availability and consistent specification sets.
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.
Always confirm 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. Review and approve the final method, then qualify it for your specific workflow and risk profile.
Source basis (manufacturer-first)
- SOSCleanroom product page (62467): https://www.soscleanroom.com/product/kimtech/kimberly-clark-kimtech-62467-m3-sterile-face-masks-w-soft-ties-7-standard/
- Manufacturer Technical Data Sheet PDF (KIMTECH PURE* M3 Sterile Pleat-Style Face Mask): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/KIMTECH%20PURE%20M3%20Sterile%20Pleat%20Style%20Face%20Mask.pdf
- Kimtech Scientific Products Catalog (manufacturer reference): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/2018%20Scientific%20Catalog.pdf
- ISO 14644-1 (classification context): https://www.iso.org/standard/53394.html
- ISO 14644-5 (operations control programme / gowning programme context): https://www.iso.org/standard/88599.html
- EU GMP Annex 1 (European sterile manufacturing context): 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
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Last reviewed: Jan. 13, 2026
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