Kimtech PURE* M3 Sterile Pleat-Style Face Mask with Knitted Earloops — White (SKU 62470) — 200/Case

Kimtech PURE* M3 (62470) is a gamma-irradiated, certified-sterile pleat-style cleanroom face mask engineered to reduce operator-borne particulate and microbial shedding during contamination-sensitive work. This version features knitted earloops, a fully enclosed, soft malleable nosepiece, and a low-lint polyethylene outer layer paired with a soft inner-facing fabric and meltblown filtration media. Each case contains 10 bags of 20 masks (200 total), and the program is designed for ISO Class 3 and higher cleanroom environments.

Cleanroom readiness highlights: Sterile (SAL 10^-6, gamma), double-bagged program, low-lint materials, and published post-sterilization filtration / breathability metrics (manufacturer datasheet).

Specifications:

Manufacturer / brand: Kimtech (KCPPE — now within the Ansell portfolio)
SOSCleanroom SKU: 62470
Mask style: Pleat-style, knitted earloops
Color: White
Size / width: 7" (18 cm), one-size format
Sterility / method: Gamma irradiated; SAL 10^-6
Recommended cleanroom level: ISO Class 3 and higher (manufacturer guidance)
Packaging: 20 masks/bag; 10 bags/case = 200 masks/case
Construction: Ultrasonic bonding; enclosed soft malleable aluminum nosepiece
Outer facing: Low-lint polyethylene (apertured film / film outer layer)
Inner facing: Soft inner-facing fabric (BiCoSof* noted in manufacturer sheet)
Filter media: Meltblown polyester (manufacturer sheet)
Published filtration (post-sterilization): PFE 89.3% @ 0.1 micron; BFE 94.1% @ 3.0 micron (manufacturer sheet)
Breathability (post-sterilization): Differential pressure 2.16 mm H₂O @ 8 LPM (manufacturer sheet)
Documentation note: Certificates of irradiation referenced by manufacturer program (availability may be program-dependent)

About the Manufacturer & Program Context:

The Kimtech cleanroom mask program is built around low-lint materials, controlled packaging, and published performance data intended for controlled environments. For audits and qualification, the most defensible approach is to anchor requirements to the manufacturer Technical Data Sheet and your facility SOP (acceptance criteria, change frequency, and gowning sequence).

Ansell relationship note: SOSCleanroom has a long-standing history supporting contamination-control programs and continues to service cleanrooms with critical supplies across industries. Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has supported cleanrooms, earning multiple distribution recognitions, including 11 Texas Instruments Supplier Excellence Awards.

62470 Features:

Knitted earloops for fast, repeatable donning and stable positioning
Fully enclosed, soft malleable nosepiece to reduce gaps and improve fit consistency
Low-lint polyethylene outer layer for contamination control
Gamma irradiated sterile program (SAL 10^-6)
Published post-sterilization performance (filtration / breathability) on manufacturer datasheet
200 masks/case (10 bags of 20) for cleanroom stocking discipline

62470 Benefits:

Reduces operator-borne contamination: supports particulate and microbial shedding control in people-intensive operations.
Supports sterile workflows: sterile mask program aligns with critical-area entry expectations when your SOP specifies sterile PPE.
Improves repeatability: standardized packaging and documented product attributes simplify qualification and receiving.
Comfort and fit consistency: earloops and enclosed nosepiece help maintain coverage over nose and chin during task work.

Common Applications:

ISO Class 3+ cleanrooms where face coverings are part of the gowning requirement
Sterile manufacturing and aseptic-support areas (SOP-dependent)
Controlled-environment staging, inspection, and packaging work where operator shedding is a key risk
General contamination-control programs that specify sterile, documented PPE components

Best-Practice Use (Mask Donning):

Don early in the gowning sequence: Put the mask on in the gowning area before entering higher-grade zones, per your SOP.
Handle by earloops: Avoid touching the mask body; treat mask surfaces as contamination-sensitive.
Fit discipline: Cover nose and chin fully; mold the enclosed nosepiece to reduce gaps.
Change when compromised: Replace if wet, damaged, or after leaving the controlled environment (SOP-driven).
No “hang-down” practice: Do not let the mask dangle from one ear; discard and replace per facility practice.

Reminder: Always follow your facility gowning SOP. Standards and guidance documents inform programs, but your validated process and training control what is acceptable in your environment.

Link to Kimtech M3 Sterile Pleat-Style Face Mask Technical Data Sheet: Click Here

Other Related Options on SOSCleanroom.com:

Kimtech M3 Sterile Pleat-Style Masks with Soft Ties (alternate tie-style format)
Kimtech M3 Cleanroom Face Masks (non-sterile cleanroom mask option)

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 PURE* M3 Sterile (Gamma) SAL 10^-6 Knitted Earloops ISO Class 3+ 200/Case

Kimtech PURE* M3 Sterile Pleat-Style Face Mask (62470) — reducing people-borne contamination through disciplined gowning and fit control

Kimtech PURE M3 sterile pleat-style face mask with knitted earloops (62470)

SKU shown: 62470 (sterile pleat-style mask with knitted earloops).

Why face masks matter in cleanrooms

In most cleanrooms, people are the dominant contamination source. Talking, breathing, coughing, facial movement, and skin/hair shedding can release particles and microorganisms that end up on critical surfaces or product. A cleanroom mask is not a "nice-to-have" accessory — it is a primary barrier that reduces emission from the mouth and nose and helps stabilize a controlled environment when used with correct gowning technique. The Kimtech PURE* M3 sterile mask program (62470) is designed to support this goal through low-lint materials, sterile processing, and manufacturer-published post-sterilization performance data.

Standards context (ISO first; Annex 1 second)

ISO 14644-1 defines cleanroom classification by airborne particle concentration. ISO 14644-5 addresses cleanroom operations and calls for an Operations Control Program that includes personnel controls and a gowning program as part of maintaining specified cleanliness levels.

For sterile medicinal product manufacturing in Europe, EU GMP Annex 1 adds expectations for contamination control strategy, risk management discipline, and gowning practices appropriate to Grades A/B/C/D. Practically: ISO establishes the cleanroom classification framework and operational program concept; Annex 1 increases rigor for sterile pharma and aseptic processing environments.

What this mask is (manufacturer-defined)

Kimtech PURE* M3 (62470) is a certified sterile, pleat-style face mask with knitted earloops. The manufacturer describes a low-lint polyethylene outer layer, a soft inner-facing fabric, meltblown filtration media, ultrasonic construction, and a fully enclosed soft malleable nosepiece. The product is gamma irradiated and validated to a Sterility Assurance Level (SAL) of 10^-6. It is supplied as 20 masks/bag, 10 bags/case (200 masks/case).

Specifications in context (receiving + qualification)

Attribute	Kimtech PURE* M3 — 62470
SKU / code	62470
Style	Pleat-style; knitted earloops; enclosed malleable nosepiece
Size / width	7" (18 cm), one-size format (manufacturer program)
Sterility / method	Gamma irradiated; SAL 10^-6
Packaging	20 masks/bag; 10 bags/case = 200 masks/case
Outer layer	Low-lint polyethylene outer layer (apertured film / film outer)
Filter media	Meltblown polyester (manufacturer sheet)
Published post-sterilization filtration	PFE 89.3% @ 0.1 micron; BFE 94.1% @ 3.0 micron (manufacturer sheet)
Published breathability	Differential pressure 2.16 mm H₂O @ 8 LPM (manufacturer sheet)
Recommended cleanroom level	ISO Class 3 and higher (manufacturer guidance)

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

ISO operations concepts (ISO 14644-5) treat gowning as a controlled process: the goal is to prevent contamination transfer from the operator to the environment and to prevent gown surfaces from contacting non-controlled surfaces. The mask is a high-impact component because it sits at the highest emission zone (mouth/nose).

Donning steps (general template — always follow your facility SOP)

Pre-gowning readiness: remove jewelry per SOP, secure hair, and perform hand hygiene before touching any cleanroom PPE.
Open clean packaging correctly: avoid snapping bags open; keep the mask from contacting counters, clothing, or the floor.
Handle only by earloops: treat the mask body as contamination-sensitive. Avoid touching the filtration area.
Fit discipline: cover nose and chin fully; mold the enclosed nosepiece to reduce gaps that can increase emission and fogging.
Sequence control: many gowning rooms place the mask before hood/coverall so the hood overlap can seal around it — but sequence is SOP-dependent.
Do not "hang down" or re-stage: if the mask is removed or becomes compromised, discard and replace per SOP.
Change triggers: replace if wet, damaged, visibly soiled, or after leaving controlled space (facility-defined).

Annex 1 overlay (European sterile manufacturing): gowning expectations are typically stricter in Grades A/B (aseptic processing support), including stronger emphasis on operator practices, garment system integrity, and contamination control strategy. If your program aligns to Annex 1, treat mask selection and change frequency as a documented risk control, not an informal habit.

Common failure modes (what causes avoidable contamination)

Touching the mask body during donning or adjustment: handle by earloops; adjust fit using the nosepiece ends rather than pressing the filtration area.
Loose fit / gaps: mold the nosepiece; ensure full nose-to-chin coverage to reduce emission.
Mask worn below the nose: defeats the primary contamination-control purpose.
Re-use after exit: re-entry with the same mask is a common contamination transfer mechanism unless explicitly permitted by SOP.
Wet mask continued in use: moisture changes filtration and comfort; replace per SOP and risk profile.

SOSCleanroom perspective: continuity, documentation, and supply

Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has supported cleanrooms with critical supplies. Our long-term servicing of contamination-control programs includes deep experience with leading manufacturers and documented performance expectations. SOSCleanroom has earned multiple distribution recognitions, including 11 Texas Instruments Supplier Excellence Awards, reflecting long-term performance in supply reliability and customer support.

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 material compatibility, 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. Your team should review and approve the final method, then qualify it for your specific facility layout, gowning sequence, contamination limits, and risk profile.

Source basis