Kimberly-Clark Kimtech M3 Cleanroom Face Masks (Non-Sterile) — Pleat Style with Knitted Earloops (500/Case)

Kimtech M3 pleat-style cleanroom face masks (SKU 62465) are designed for contamination-control “source control” in ISO Class 3 and higher cleanroom environments. This non-sterile mask uses a low-linting polyethylene outer layer with a soft inner-facing layer for comfort, plus ultrasonically bonded knitted earloops and a fully enclosed, bendable nosepiece to support a stable, repeatable fit during longer wear. For cleanroom programs, the practical goal is simple: reduce operator-generated contamination (particles, droplets, and fibers) while keeping comfort high enough that employees wear masks correctly and consistently.

Important use note: This is a cleanroom contamination-control face mask. It is not a respirator and is not intended to provide respiratory protection from harmful vapors, gases, or airborne hazards. Follow your site EHS and PPE program for hazard protection requirements.

Specifications:

Manufacturer / brand: Kimtech (Kimberly-Clark Professional; Kimtech portfolio now supported under Ansell)
SKU: 62465
UPC: 036000624656
Sterility: Non-sterile
Mask style: Pleat-style cleanroom face mask
Attachment: Knitted earloops; ultrasonically bonded
Nosepiece: Fully enclosed, soft, bendable nosepiece
Outer layer: Low-linting polyethylene film (cleanroom-compatible outer surface)
Inner-facing layer: Soft inner-facing layer for comfort
Recommended cleanroom level: ISO Class 3 and higher (process- and SOP-dependent)
Filtration performance (published): BFE ≥ 99% and PFE ≥ 99% (see manufacturer PDS for test methods and particle size conditions)
Breathability (published): Differential pressure < 5 mm H₂O/cm² (per manufacturer PDS test method)
Particle generation (published): Helmke Drum Category I (low particle generation; see manufacturer PDS)
Color / size: White; one size
Case pack: 500 masks/case (10 boxes of 50)
Packaging: Double bagged (cleanroom entry-friendly handling)

About the Manufacturer:

Kimtech cleanroom PPE is built for controlled environments where “comfort” must exist alongside low-lint materials, controlled packaging, and published performance data. The M3 mask family is widely used in microelectronics and precision manufacturing environments where cleanroom discipline depends on consistent daily habits (fit, handling, change-outs, and correct donning).

SOSCleanroom relationship and continuity: Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has supported cleanrooms with critical supplies. We have long-standing manufacturer relationships across the cleanroom category, including deep experience servicing contamination-control programs and demanding customer scorecards (including 11 Texas Instruments Supplier Excellence Awards).

M3 Mask Features:

Low-lint polyethylene outer layer to help reduce fiber shedding risk from the mask surface
Soft inner-facing layer designed for comfort during longer wear
Ultrasonically bonded knitted earloops and enclosed bendable nosepiece for consistent fit
Double-bag packaging to support controlled entry handling practices
Published filtration and breathability performance (see manufacturer PDS for test methods and conditions)

Benefits for Cleanroom Programs:

Reduces operator-sourced contamination: Helps control droplets and particles generated by speaking, breathing, and routine movement (source control).
Consistency across shifts: Standardized construction and packaging helps reduce “operator variability.”
Comfort supports compliance: If the mask is uncomfortable, employees touch it more and adjust it more—both of which increase contamination risk.
Cleanroom-ready handling: Double-bag packaging supports gowning-room discipline and controlled entry workflows.

Common Applications:

Semiconductor, disk drives, data storage, and integrated circuits
Optics, precision assemblies, and sensitive inspection areas
Medical device manufacturing (non-sterile areas where a cleanroom mask is specified by SOP)
General controlled environments where ISO Class 3+ gowning programs require face covering

Best-Practice Use (Donning / Gowning Focus):

Don in the correct sequence: Follow your gowning SOP. In many cleanrooms, the mask is donned after hair/beard cover and before hood/coverall final closure (sequence is SOP-dependent).
Hands first: Perform required hand hygiene before touching the mask packaging and mask.
Only handle straps: Avoid touching the mask’s front/filter area. Treat the front as contamination-sensitive.
Fit matters: Shape the nosepiece to reduce gaps. Ensure full coverage over nose and under chin.
Change-out discipline: Replace masks per SOP (time-in-use, moisture, damage, or contamination event).
Do not “stage” masks: Avoid placing masks on benches, pockets, or non-controlled surfaces during gowning.

Program note: ISO cleanroom performance depends on discipline (donning, behavior, and change-out control) as much as it depends on the garment. If you are operating under EU sterile manufacturing expectations, align gowning training and garment selection with your Annex 1 risk assessment and SOP requirements.

Selection Notes (Non-Sterile vs. Sterile Options):

Non-sterile vs. sterile masks: Choose sterile when your SOP requires sterile packaging and sterilization documentation for controlled entry into critical aseptic areas.
Earloops vs. ties: Earloops are fast and convenient; ties can support a more adjustable fit and may reduce ear fatigue for long wear (SOP- and comfort-dependent).
Pleat style vs. pouch style: Pouch/breathing-chamber masks can improve comfort and airflow for some users; pleat masks are common for general controlled environments.

Link to Manufacturer Product Data Sheet (PDS): Click Here

Related (Sterile) M3 Mask Options at SOSCleanroom.com:

Complete the contamination-control workflow: Masks reduce operator-sourced contamination, but surface control still matters. Many cleanrooms pair gowning programs with compatible cleanroom wipers and swabs (including Texwipe options) for wipe-down and tool cleaning steps.

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

Non-Sterile Pleat Style Knitted Earloops ISO Class 3+ (Program Fit) 500/Case Latex & Silicone Free Not a Respirator

Kimtech M3 Cleanroom Face Masks (SKU 62465) — practical source control and donning discipline for ISO Class 3+ environments

Kimtech M3 Cleanroom Face Masks (Non-Sterile) - pleat style with knitted earloops

SKU shown: 62465 (non-sterile Kimtech M3 pleat-style mask with knitted earloops).

Why cleanroom masks matter (source control, not hazard protection)

In controlled environments, people are often the largest contamination source. Talking, breathing, and routine movement generate particles and droplets that can deposit onto product, tooling, and sensitive surfaces. Cleanroom masks are primarily used for source control: reducing what the operator releases into the environment. The Kimtech M3 cleanroom mask is not a respirator and is not intended to protect against chemical vapors, gases, or airborne hazards.

Where this product is typically used

ISO Class 3 and higher cleanrooms where a non-sterile cleanroom mask is specified by SOP and risk assessment.
Microelectronics and precision manufacturing areas (semiconductor, disk drives, data storage, integrated circuits).
Controlled inspection and assembly areas where operator comfort and consistent mask-wear compliance matter.
General cleanroom programs where packaging discipline (double-bag) supports controlled entry workflows.

Why customers select the M3 mask family

Cleanroom-compatible construction: low-lint outer layer and controlled manufacturing attributes published in the PDS.
Published filtration + breathability: performance is published with test-method references.
Comfort drives compliance: comfortable masks reduce face-touching and mid-shift adjusting, both of which elevate contamination risk.
Packaging discipline: double-bag handling supports better gowning-room control.
Supply continuity: SOSCleanroom has supported cleanrooms since 1981 with stable supply and documentation support.

Materials and construction

The M3 pleat-style mask is described with a low-lint polyethylene outer layer and a soft inner-facing layer. A fully enclosed bendable nosepiece supports fit stability. The earloops are ultrasonically bonded to reduce loose fibers and improve cleanroom compatibility.

Specifications in context

Attribute	Kimtech M3 (SKU 62465)
Sterility	Non-sterile
Recommended cleanroom level	ISO Class 3 and higher (program/SOP dependent)
Outer / inner layers	Low-lint polyethylene outer; soft inner-facing layer
Fit features	Knitted earloops; enclosed bendable nosepiece
Filtration (published)	BFE ≥ 99%; PFE ≥ 99% (see PDS for test methods/particle sizes)
Breathability (published)	Differential pressure < 5 mm H₂O/cm²
Particle generation (published)	Helmke Drum Category I (low particle generation)
Packaging	500/case (10 boxes of 50); double bagged
Respiratory protection	Not a respirator; not intended for hazardous airborne protection

Performance and cleanliness considerations

Characteristic	What it means for use	Published basis
BFE / PFE	Supports source control by reducing release of bacteria-associated droplets and particulates.	Manufacturer PDS (ASTM-based methods).
Breathability (ΔP)	Lower breathing resistance reduces "mask fiddling" and improves compliance.	Manufacturer PDS (ASTM-based method).
Particle generation	Lower particle generation supports cleaner airflow in critical areas.	Helmke Drum category in manufacturer PDS.
Not a respirator	Do not substitute cleanroom masks for hazard protection.	Manufacturer/Seller positioning.

Packaging and handling

Masks often become contaminated during donning, not during use. Double-bag packaging helps reduce exposure during controlled entry, but only if operators follow handling discipline: open bags in the right zones, avoid bench placement, and only handle straps/edges. Treat the mask front as contamination-sensitive.

Donning education: ISO-first, then EU Annex 1 context

ISO-first donning discipline

Step 1: complete required hand hygiene; minimize talking; move deliberately.
Step 2: ensure all hair is fully contained before mask placement.
Step 3: handle only earloops; seat mask over nose and under chin; shape nosepiece to reduce gaps.
Step 4: once donned, avoid adjusting the mask front. If fit is wrong, replace rather than "rework."
Step 5: ensure hood/coverall closure does not dislodge the mask and does not leave exposed skin in the breathing zone.
Step 6: replace masks if wet, damaged, contaminated, or at SOP-defined time intervals.

EU Annex 1 context: Annex 1 places increased emphasis on contamination-control strategy, gowning suitability, and training discipline for sterile medicinal product manufacture. If your facility operates under Annex 1 expectations, ensure mask selection (sterile vs. non-sterile), gowning sequence, and change-out cadence are explicitly defined by SOP and risk assessment.

Common failure modes

Mask below the nose: defeats source control; retrain immediately.
Repeated face-touching/adjusting: increases contamination risk; replace mask if fit is poor.
Loose nose fit / side gaps: reshape nosepiece; confirm compatible eyewear/hood interface.
Improper storage: pocketing or bench placement contaminates masks; do not reuse staged masks.
Wrong product for the grade: use sterile masks and higher-spec gowning where SOP/grade requires it.

Closest alternatives

Kimtech M3 sterile pleat-style masks: when SOP requires sterile packaging and sterilization documentation.
Kimtech M3 pouch-style sterile masks: when comfort/airflow and breathing chamber are prioritized in aseptic workflows.
Other cleanroom mask programs: compare published test methods and particle generation categories—not just "filtration" claims.

Critical environment fit

The non-sterile Kimtech M3 earloop mask is a strong fit for ISO Class 3+ controlled environments where the contamination-control objective is operator source control and where non-sterile PPE is acceptable by SOP.

SOSCleanroom note about SOPs

The Technical Vault is written to help customers make informed contamination-control decisions and strengthen day-to-day technique. It is not your facility's Standard Operating Procedure (SOP), validation protocol, or batch record.

Customers are responsible for establishing, training, and enforcing SOPs that fit their cleanroom classification, products, processes, and regulatory obligations.

If you adapt any guidance from this entry, treat it as a starting template. Review internally, approve formally, then qualify it for your specific risk profile.

Source basis