Kimtech M3 Certified Sterile Pleat-Style Face Masks with Soft Ties — White (7" or 9" Option) — 200/Case

Kimtech M3 sterile pleat-style face masks with soft ties are designed for controlled environments where reducing operator-borne contamination and maintaining documentation discipline matters. This soft-tie format supports a secure, customizable fit and is supplied sterile via gamma irradiation to a published Sterility Assurance Level (SAL) of 10^-6. Each case includes 10 bags of 20 masks (200 masks/case). Select the size option that matches your facility preference: 7" (standard) or 9" (large).

Qualification note: Performance values (post-sterilization PFE/BFE and breathability) and material construction below are taken from the manufacturer Technical Data Sheet.

Specifications:

Brand: Kimtech
Product family: M3 Certified Sterile Pleat-Style Face Mask (Soft Ties)
Size options (manufacturer codes): 7" (Code 62467) or 9" (Code 62494)
Color: White
Style: Pleated mask with soft ties (tie-style for adjustable fit)
Sterility / method: Gamma irradiated; SAL 10^-6
Recommended cleanroom level: ISO Class 3 or higher (manufacturer guidance)
Packaging: 20 masks/bag; 10 bags/case = 200 masks/case
Packaging discipline: Manufacturer states masks are double bagged
Construction: Ultra sonic bonding; fully enclosed, soft, malleable aluminum nosepiece
Outer facing: Clear polyethylene, apertured film (low-lint outer layer)
Inner facing: White BiCoSof* fabric (manufacturer description)
Filter media: White, meltblown polyester
Published post-sterilization performance (TDS): PFE 89.3% @ 0.1 micron; BFE 94.1% @ 3.0 micron; Differential pressure 2.16 mm H₂O @ 8 LPM
Documentation: Manufacturer notes certificates of irradiation availability (program-dependent)

About the Manufacturer & SOSCleanroom Support:

Kimtech cleanroom masks are built around low-lint materials, controlled packaging, and published test results intended for controlled environments. For audits and qualification, anchor your acceptance criteria to the manufacturer datasheet and your facility SOP (fit requirements, donning sequence, change frequency, and disposal rules).

Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has supported cleanrooms with critical supplies. Our long-standing service record includes major contamination-control manufacturers (including Ansell programs) and decades of support for high-requirement operations, with multiple distribution recognitions including 11 Texas Instruments Supplier Excellence Awards.

M3 Soft-Tie Features:

Soft ties for adjustable fit and stable positioning
Fully enclosed soft, malleable aluminum nosepiece to reduce gaps
Low-lint polyethylene apertured film outer layer (manufacturer construction)
Gamma irradiated sterile program (SAL 10^-6)
Published post-sterilization performance (PFE/BFE and breathability) on manufacturer TDS
Double-bagged program (manufacturer statement)

Common Applications:

ISO Class 3+ controlled environments where mask fit stability is part of the gowning control
Sterile/critical operations requiring sterile PPE components (SOP-dependent)
People-dense cleanroom work (inspection, packaging, staging) where emission control is a key risk

Selection Notes (7" vs. 9" Soft-Tie Option):

7" (Code 62467): common “standard” size for general cleanroom use where a smaller footprint is preferred.
9" (Code 62494): larger format often selected when broader facial coverage or fit stability is preferred (site-dependent).
Soft ties vs. earloops: ties can improve fit control and reduce “slip” during extended wear; earloops can be faster for quick donning (SOP and comfort dependent).

Link to Manufacturer Technical Data Sheet (KIMTECH PURE* M3 Sterile Pleat-Style Face Mask): Click Here

Other Related Options on SOSCleanroom.com:

Kimtech M3 Sterile Pleat-Style Masks with Knitted Earloops (alternate donning/fit format)
Kimtech M3 Sterile Pouch-Style Masks with Two Knitted Headbands (alternate mask construction)
Kimtech M3 Cleanroom Face Masks (non-sterile option, SOP-dependent)

Common Pairings (Contamination-Control Support)

Texwipe TX1009 AlphaWipe: cleanroom wiper option often used in controlled wipe-down programs (process-dependent).
Texwipe TX761 Cleanroom Swab: targeted cleaning for tight areas and equipment interfaces (qualification-dependent).

Notes: Need help selecting masks, hoods, garments, and compatible wipe-down supplies for your ISO class and workflow? Contact SOSCleanroom for practical selection guidance grounded in real cleanroom routines.

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

Product page updated: Jan. 13, 2026 (SOS Technical Staff)

© 2026 SOS Supply. All rights reserved.

The Technical Vault

By SOSCleanroom

Kimtech M3 Sterile (Gamma) SAL 10^-6 Soft Ties 7" or 9" Option ISO Class 3+ 200/Case

Kimtech M3 Sterile Soft-Tie Pleat-Style Masks — reducing people-borne contamination through disciplined donning and fit control

Why masks are a first-order contamination control

In most cleanrooms, people are the dominant contamination source. Speech, breathing, facial movement, and skin/hair shedding can release particles and microorganisms that migrate to critical surfaces and product. A cleanroom face mask is a primary barrier that reduces emission from the mouth and nose — but only if it is donned correctly and kept in position. Soft ties are often selected when a site wants more stable fit control than earloops.

Standards context (ISO first; Annex 1 second)

ISO 14644-1 defines cleanroom classification by airborne particle concentration — the ISO Class number is the standard language used across industries to specify air cleanliness. ISO 14644-5 (Operations) requires an Operations Control Programme (OCP) for maintaining cleanliness, including a personnel management programme that includes a gowning programme. Practically: ISO defines the “target environment” and the operational controls that help keep it there.

For European sterile medicinal manufacturing, EU GMP Annex 1 increases rigor for sterile programs by emphasizing contamination control strategy, risk management discipline, monitoring, and personnel gowning appropriate to Grades A/B/C/D. If your facility aligns to Annex 1, mask control (selection, donning, change triggers, and behavior) should be documented as a deliberate contamination-risk control — not an informal habit.

Manufacturer-defined product identity (datasheet anchored)

The manufacturer Technical Data Sheet defines the Kimtech M3 sterile pleat-style soft-tie masks under codes 62467 (7") and 62494 (9"), supplied as 20 masks per bag, 200 per case. The program is described as double bagged and gamma irradiated to a published SAL of 10^-6, recommended for Class 3 (ISO Class 3) or higher cleanroom environments.

Specifications in context (receiving, qualification, and SOP alignment)

Attribute	Kimtech M3 Soft-Tie Sterile Masks
Manufacturer codes / size options	62467 (7"), 62494 (9")
Sterility / method	Gamma irradiated; SAL 10^-6
Packaging	20/bag; 200/case; double bagged (manufacturer statement)
Construction	Pleated; spunlaced polyester ties/binding; fully enclosed soft malleable aluminum nosepiece; ultrasonic bonding
Materials (datasheet)	Outer: clear polyethylene apertured film; Inner: BiCoSof* fabric; Filter: meltblown polyester
Published post-sterilization performance	PFE 89.3% @ 0.1 micron; BFE 94.1% @ 3.0 micron; Differential pressure 2.16 mm H₂O @ 8 LPM (per TDS)
Recommended cleanroom level	Class 3 / ISO Class 3 and higher (manufacturer guidance)

Proper gowning (donning) education: soft-tie mask technique that minimizes contamination

ISO operations expectations are met through behavior control and repeatable technique. A mask is only protective when it stays in the correct position and is handled correctly. Soft ties can reduce “slip” compared to earloops, but they also introduce a failure mode: loose, dangling ties contacting garments or surfaces.

Donning steps (general template — follow your facility SOP)

Hand hygiene first: perform hand hygiene before opening sterile PPE packaging.
Open without “bag snap”: avoid fast motions that can aerosolize particles in the gowning area.
Handle ties — not the mask body: treat the filtration area as contamination-sensitive.
Position correctly: cover nose and chin fully before tying.
Tie sequence control: commonly bottom tie first (to anchor), then top tie (to seal at the nose/cheek area). Keep tie ends controlled — do not let them brush garments or benches.
Seal the nosepiece: mold the enclosed nosepiece to reduce gaps that increase emission and fogging.
Change triggers: replace if wet, damaged, or after exiting controlled space unless your SOP explicitly allows re-entry reuse.

Annex 1 overlay: for sterile medicinal products, personnel controls (including gowning) are treated as high-impact contamination controls under the site’s contamination control strategy. If you operate under Annex 1 expectations, tie discipline, mask change frequency, and behavior rules should be trained, assessed, and audited as part of routine operations.

Common failure modes (what causes avoidable contamination)

Loose or untied tails: tie ends contacting garments or benches is a frequent contamination transfer path.
Mask body touched during adjustment: adjust using ties and the nosepiece ends rather than pressing the filtration area.
Mask worn below the nose: defeats the primary contamination-control purpose.
Re-use after exit without SOP allowance: re-entry with the same mask can import contamination from uncontrolled areas.
Wet mask continued in use: moisture changes comfort and can destabilize fit; replace per SOP.

SOSCleanroom continuity note (service history and support)

Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has supported cleanrooms with critical supplies. Our long-term service record includes major contamination-control manufacturers (including Ansell programs) and decades of support for high-requirement operations. SOSCleanroom has earned multiple distribution recognitions, including 11 Texas Instruments Supplier Excellence Awards, reflecting sustained performance in supply reliability and customer support.

Source basis (manufacturer-first)

SOSCleanroom product page (soft-tie option): https://www.soscleanroom.com/product/kimtech/kimberly-clark-kimtech-m3-sterile-face-masks-with-soft-ties-pleat-style/
Manufacturer Technical Data Sheet (Codes 62467, 62470, 62494): https://www.soscleanroom.com/content/Kimberly_Clark_PDF/KIMTECH%20PURE%20M3%20Sterile%20Pleat%20Style%20Face%20Mask.pdf
ISO 14644-1 (classification context): https://www.iso.org/standard/53394.html
ISO 14644-5 (operations / gowning program context): https://www.iso.org/standard/88599.html
EU GMP Annex 1 (sterile manufacture / gowning 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

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

Last reviewed: Jan. 13, 2026