KP Protective Face Mask
MEDICAL GRADE RESPIRATOR
KP Protective Mask
ADVANCED FILTRATION TECHNOLOGY
Protective Mask Features
High-efficiency melt-blown filter
blocks >95% of particles.
Lightweight materials allow for comfortable all-day wear.
Fog-less enhanced breathability
STRUCTURAL INNOVATION
3D patented design
Device Description
Product Overview
Description & Layers
The KP Protective Face Mask is a non-sterile, single-use surgical mask intended to cover the user’s nose and mouth, providing a physical barrier to fluids, microorganisms, and particulate matter.
The mask consists of three nonwoven polypropylene layers:
- Outer layer: Spunbond non-woven
- Filter layer: Melt-blown polypropylene
- Inner comfort layer: Spunbond non-woven
- Nose wire: Polypropylene-clad adjustable wire
- Attachment: Elastic earloops (Nylon/Polyurethane mix)
The mask is white, flat-fold style, supplied non-sterile, and packaged in standard pouches.
Intended Use
The KP Protective Face Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Materials & Dimensions
Technical Specifications
Materials
- Outer Cover Web: Polypropylene Spunbond Non-woven fabric (40gsm, SSS)
- Filter Web: Polypropylene Melt blown non-woven fabric (40gsm, FFP2, Water Agent process)
- Inner Web: Polypropylene Spunbond Non-woven fabric (20gsm, SSS)
- Nose-Clip: Polypropylene clad wire
- Ear Loop: A mixture of Nylon and Polyurethane strap
Spec & Dimension
Color
White
Length
205 ± 10mm
Width
85.1 ± 6.4mm
Earloops Length
165 ± 16mm
Style
Flat fold, Multi
(three layers)
Sterility
Non-Sterile Single Use
Summary of Testing
Performance Reports
The KP Protective Face Mask was evaluated in accordance with ASTM F2100-19 Level 2 requirements. Testing included BFE, PFE, Synthetic Blood Penetration, Differential Pressure, Flammability, and Biocompatibility (ISO 10993).
Performance Testing Summary
| TEST METHOD | PURPOSE | ACCEPTANCE | RESULTS |
|---|---|---|---|
| ASTM F2101 | Measure filtration efficiency against S. aureus aerosol | ≥98% (Level 2) | PASS ≥99% |
| ASTM F3502-25 | Measure submicron particle filtration (0.1µm) | ≥85 (Level 2) | PASS ≥85% |
| ASTM F1862 | Evaluate resistance to synthetic blood at pressure | 120 mmHg - No penetration | PASS – no penetration |
| EN 14683 / MIL-M-36954 | Measure breathability (ΔP) | < 6.0 mmH2O/cm² (Level 2) | PASS |
| 16 CFR 1610 | Evaluate flammability of mask materials | Class 1 (Normal flammability) | PASS - Class 1 |
Biocompatibility Testing
| TEST METHOD | PURPOSE | ACCEPTANCE | RESULTS |
|---|---|---|---|
| ISO 10993-10:2010 | Irritation | Primary irritation index (PII) ≤ 0.4 | PII = 0.0, No irritation observed |
| ISO 10993-10:2010 | Sensitization | 0% Sensitization response | 0% response, no sensitization |
| ISO 10993-5:2019 | In vitro Cytotoxicity | ≥ 70% cell viability | Non-Cytotoxic |