Masks & Respirators

Product Variants

Respiratory Protection for Every Clinical Setting

From standard procedure masks to NIOSH-certified N95 respirators, we carry the full spectrum of respiratory protection required in clinical environments.

N95 Filtering Facepiece Respirators

NIOSH-Approved · ≥95% Filtration

NIOSH-certified N95 respirators filtering ≥95% of airborne particles. Required for aerosol-generating procedures per CDC HICPAC 2026 guidance. Cup-style and flat-fold options available.

CertificationNIOSH (42 CFR Part 84)

Filtration≥95% (0.3µm particles)

StylesCup, Flat-fold

StrapsHeadband / Earloop

Pack Size20/box · 480/case

ASTM Level 3 Surgical Masks

High Fluid Resistance · OR-Grade

Highest ASTM fluid resistance rating for operating room and high-splatter procedure environments. BFE ≥98%, PFE ≥98%, fluid resistance ≥160mmHg.

StandardASTM F2100 Level 3

BFE / PFE≥98% / ≥98%

Fluid Resistance≥160 mmHg

StyleTie-back, Earloop

Pack Size50/box · 600/case

ASTM Level 2 Surgical Masks

Moderate Fluid Resistance · Standard Procedure

Mid-level surgical masks for most clinical and procedural settings. Balances breathability with solid fluid barrier protection. The most widely used mask in hospital settings.

StandardASTM F2100 Level 2

BFE / PFE≥98% / ≥98%

Fluid Resistance≥120 mmHg

StyleEarloop, Pleated

Pack Size50/box · 600–1000/case

Surgical N95 Respirators

NIOSH + FDA Cleared · Fluid Resistant

Dual-certified as both a surgical mask (FDA 510(k)) and NIOSH-approved N95 respirator. Required for surgical procedures on patients with airborne infectious diseases.

CertificationsNIOSH + FDA 510(k)

Filtration≥95%

Fluid Resistance≥120 mmHg

StyleCup, Duckbill

Pack Size20/box · 240/case

ASTM Level 1 / Procedure Masks

Low Fluid Resistance · General Use

Suitable for routine patient care, visitor use, and low-risk procedures. Available in standard 3-ply and with anti-fog nose bar. Bulk-priced for high-volume dispensing throughout a facility.

StandardASTM F2100 Level 1

BFE≥95%

StyleEarloop, Anti-fog

ColorsBlue, White, Black, Assorted

Pack Size50/box · 1,000+/case

KN95 Masks

GB2626-2019 · ≥95% Filtration

Chinese standard KN95 masks offering ≥95% particle filtration. An alternative to N95 for non-surgical settings where NIOSH certification is not required. Often more cost-effective for high-volume non-OR use.

StandardGB2626-2019

Filtration≥95% (NaCl)

StyleFlat-fold, Cup

StrapsEarloop

Pack Size10/bag · 200/case

Technical Specifications

Comparison by Product Type

Specification	N95 Respirator	ASTM L3 Surgical	ASTM L2 Surgical	Surgical N95	KN95
Filtration Efficiency	≥95% (NIOSH)	≥98% BFE	≥98% BFE	≥95% + ≥98% BFE	≥95% (GB)
Fluid Resistance	Not rated	≥160 mmHg	≥120 mmHg	≥120 mmHg	Not rated
NIOSH Approved	Yes	No	No	Yes	No
FDA Listed	Varies	Yes	Yes	Yes (510k)	No
Aerosol-Gen Procedures	Yes	No	No	Yes	No (non-OR)
Surgical Use (OR)	No (non-surgical)	Yes	Yes	Yes	No
Fit Test Required	Yes (OSHA)	No	No	Yes (OSHA)	No
Typical Use Setting	Isolation, AGMP	OR, trauma	General procedure	OR + AGMP	Non-clinical, general

Regulatory Compliance

Certifications We Provide

😷

NIOSH 42 CFR Part 84

National Institute for Occupational Safety and Health approval — the gold standard for respiratory protection in US healthcare settings.

🧪

ASTM F2100 (Level 1/2/3)

American Society for Testing and Materials standard governing bacterial filtration, particle filtration, fluid resistance, and breathability for surgical masks.

🏛️

FDA 510(k) Clearance

FDA clearance as a Class II medical device (21 CFR 878.4040 for surgical masks; surgical N95s hold dual clearance).

⚙️

ISO 13485

Quality management system certification held by all our mask and respirator manufacturing partners, ensuring consistent production standards.

Respiratory Protection for Every Clinical Setting

Comparison by Product Type

Certifications We Provide

Complete Your Respiratory Program