SKU shown: 62494 (M3 sterile pleat-style mask, 9" Large, soft ties).
Why cleanrooms treat masks as contamination-control equipment
In most controlled environments, people are the dominant contamination source: skin flakes, fibers, droplets, and particles released during talking and breathing.
A cleanroom mask is not “just PPE”—it is part of the facility’s contamination-control strategy that reduces what escapes from the mouth/nose region into airflow paths and onto product-adjacent surfaces.
The Kimtech M3 sterile mask is designed to support that discipline with low-linting construction, stable soft-tie fit, and sterile packaging for programs that require sterile PPE.
What this product is (per manufacturer)
Kimtech™ PURE M3 sterile pleat-style face masks use ultrasonic bonding, a fully enclosed soft/bendable nosepiece,
and a low-linting material stack designed for cleanroom use. Manufacturer states masks are gamma irradiated to a SAL of 10-6 and double bagged.
Case pack is 200 masks (10 bags of 20), sized 9" (Large) for broader facial coverage where SOP requires it.
Specifications in context (from manufacturer datasheet)
| Attribute |
Kimtech M3 Sterile (62494) |
Why it matters in cleanrooms |
| Sterility |
Gamma irradiated; SAL 10-6; double bagged |
Supports sterile-area entry programs and documentation expectations where sterile PPE is required. |
| Fit system |
Soft ties; enclosed bendable nosepiece |
Tie systems help reduce slippage and repeated re-adjustment that can add touch contamination. |
| PFE (post-sterilization) |
89.3% @ 0.1 micron (ASTM F1215-89) |
Indicates particulate capture performance in a small particle test context (use SOP/risk assessment for acceptance). |
| BFE (post-sterilization) |
94.1% @ 3.0 microns (MIL-M-36954C) |
Relevant to droplet-associated bacterial aerosol test context; not a substitute for facility contamination controls. |
| Breathability (post-sterilization) |
2.16 mm H2O @ 8 LPM (MIL-M-36954C) |
Comfort planning: improves compliance with “do not touch / do not adjust” expectations during work. |
| Material stack (summary) |
PE film outer; BiCoSof™ inner; meltblown polyester filter; polyester ties |
Low-linting design intent supports reduced fiber release vs. general-purpose masks (qualification still required). |
| Pack |
20/bag; 200/case (10 bags) |
Supports controlled issue and stocking for gowning rooms. |
ISO-first: what “proper gowning” is trying to accomplish
ISO cleanroom standards frame the goal: maintain a classified environment by controlling contamination sources during operation.
ISO 14644-1 defines the air cleanliness classification framework, while ISO 14644-5 addresses operational controls (personnel behavior, entry/exit discipline, cleaning, and contamination control programs).
In practical terms: you do not “wear PPE,” you execute a repeatable contamination-control method at the gowning boundary.
Cleanroom donning fundamentals (mask-specific discipline included)
- Start “clean to cleaner”: enter the gowning area in the correct zone order and keep street-side items out of the clean side.
- Hand hygiene is not optional: sanitize/wash as defined by SOP before touching any cleanroom PPE packaging.
- Mask donning (soft-tie): hold mask by ties, position over nose/mouth, tie top ties on the crown, then bottom ties at the neck; mold nosepiece once; avoid repeated adjustments.
- Outside stays outside: treat the mask exterior and garment exteriors as “do not touch” surfaces once donned.
- Control sterile transfer: for double-bag items, SOP defines where to remove outer bag vs. inner bag to protect the sterile presentation.
- Final mirror check: confirm coverage, tie placement, nosepiece fit, and no exposed facial hair (if applicable) before entry.
Cleanroom masks are contamination-control PPE, not respirators. If airborne hazards exist, your EHS program determines required respiratory protection.
European Annex 1 overlay: sterile manufacturing mindset (when applicable)
EU GMP Annex 1 (sterile medicinal products) raises the bar on personnel controls by emphasizing a facility-wide Contamination Control Strategy (CCS),
personnel qualification, and disciplined gowning practices that reduce microbial and particulate risk in aseptic operations.
If you operate under Annex 1 expectations (or supply into Annex 1-regulated markets), align mask selection and donning technique with your CCS, gown qualification, and training program.
- Consistency wins audits: sterile PPE + trained technique + documented change frequency beats “good intentions.”
- Touch reduction is the point: ties, coverage, and comfort matter because they reduce mid-process adjustments.
- Use sterile presentation correctly: double-bag transfer steps and glove sanitization moments should be defined, trained, and verified.
Handling & sterile transfer: make “double bagged” actually work
Manufacturer states masks are double bagged. The benefit is only realized when the facility uses the packaging correctly.
A common SOP approach is: remove the outer bag at the appropriate boundary (often the gowning room / less-clean side), present the inner bag forward, then open the inner bag only in the cleaner zone with sanitized gloves.
Your site SOP governs the exact steps, but the goal is always the same: keep the “sterile/clean presentation” from contacting lower-grade surfaces or unsanitized gloves.
Practical technique tip
If operators frequently re-tie, re-seat, or “neck-hang” masks, contamination risk increases. In that case, consider re-training on tie placement, selecting the correct size (standard vs. large),
and confirming comfort/breathability as part of PPE qualification.
Common failure modes (and what to correct)
- Touching the mask front: re-train “handle by ties,” and sanitize gloves after any accidental contact per SOP.
- Mask worn on the neck: treat as contaminated and replace; do not re-don.
- Loose ties / slipping: tie top ties higher on crown and bottom ties at neck; confirm size selection.
- Nosepiece gaps / fogging: mold once, gently; check compatibility with eyewear/hood and minimize repeated adjustments.
- Sterile packaging mishandled: enforce outer/inner bag removal points and glove sanitization steps at the boundary.
Selection notes (when to choose a different mask)
- Sterile vs. non-sterile: choose sterile when SOP/CCS requires sterile PPE for entry or aseptic activities; otherwise qualify non-sterile options where permitted.
- Soft ties vs. earloops: ties can improve stability and reduce re-adjustments; earloops can be faster for lower-criticality zones (SOP governs).
- Standard vs. Large: large sizes can improve coverage for some users; select the size that reduces gaps and mid-shift repositioning.
Critical environment fit for this product
Kimtech M3 sterile masks are typically selected for cleanrooms where sterile PPE is required and where personnel technique is actively managed as part of contamination control.
Manufacturer recommends this mask family for ISO Class 3 and higher environments. Qualification remains site-specific: confirm SOP acceptance criteria, comfort, and change frequency using your internal quality system.
SOSCleanroom note about SOP's
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 material suitability, sterile-handling steps, change frequency, 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. Your team should review and approve the final method, then qualify it for your specific risks and process needs.
Source basis (manufacturer-first)
- SOSCleanroom product page (62494): https://www.soscleanroom.com/product/kimtech/kimberly-clark-kimtech-62494-m3-sterile-face-masks-w-soft-ties-9-large/
- Manufacturer datasheet (Kimtech PURE M3 Sterile Pleat Style Face Mask; revised April 2014): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/KIMTECH%20PURE%20M3%20Sterile%20Pleat%20Style%20Face%20Mask.pdf
- Kimtech Scientific Products Catalog (reference/gowning context): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/2018%20Scientific%20Catalog.pdf
- ISO cleanroom classification context (ISO 14644-1): https://www.iso.org/standard/53394.html
- ISO operations context (ISO 14644-5): https://www.iso.org/standard/88599.html
- EU GMP Annex 1 (sterile medicinal products; personnel/gowning context): https://www.gmp-compliance.org/files/guidemgr/20220825_gmp-an1_en_0.pdf
- Kimtech certificate portal (as referenced by manufacturer datasheet): www.kimtech.com/certificates
SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has been supporting cleanrooms with critical supplies (including long-term manufacturer partnerships and multiple supplier excellence awards).
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Last reviewed: Jan. 14, 2026
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