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3-Ply Medical Surgical Face Mask FDA CE Disposable High Filtration Earloop Mask for Hospital Bulk OEM Supplier

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Product Description

🔹 Basic Information

Model NO.:FM0039
Sterilization:Without Ethylene Oxide
Guarantee Period:Five Years
Group:Adult
Material:Nonwoven + Meltblown + Nonwoven
BFE:≥98%
Style:Earloop
Size:17.5*9.5cm
Application:Hospital / Surgery / Clinic / Laboratory
Standard:ASTM Level 2 / Level 3
Approval:FDA 510K / CE
Fluid Resistance:120-160 mmHg

🔹 Product Description

3-Ply Medical Surgical Face Masks for Hospitals & Clinics

Designed for high-risk medical environments requiring superior filtration and fluid resistance. The Breathable Protective Medical 3-Ply Non-Woven Disposable Surgical Face Mask provides reliable filtration and comfort for medical and daily use. Featuring a 3-layer protective structure and soft earloops, it ensures high breathability and professional-grade protection.

Item Specification
MaterialNonwoven + Meltblown + Nonwoven
Layers3-Ply
StandardASTM Level 2 / 3
ApprovalFDA 510K / CE
BFE/PFE≥98%
Fluid Resistance120-160 mmHg
Size17.5×9.5 cm
Packing50 pcs/box, 2000 pcs/carton

🔹 Key Features

  • 3-Layer Protection System - Outer fluid-resistant layer + melt-blown filtration + soft inner layer
  • High Breathability - Comfortable for long-term wear without stuffiness
  • Elastic Earloop Design - Secure and soft earbands reduce pressure
  • Medical & Surgical Grade - Suitable for hospitals, clinics, laboratories
  • High Filtration Efficiency - Optional BFE ≥ 95% / 98%

🔹 Detailed Photos

Medical Mask Front View
Medical Mask Side View
Medical Mask Detail View

🔹 Technical Specifications

1. Conform to FDA 510K (No:K101000).
2. Glass fiber-free and latex-free.
3. Breathing Resistance (Delta P) < 6.0.
4. Bacterial Filtration Efficiency (BFE%) > 99%
5. Particle Filtration Efficiency (PFE%) > 99%.

Standard Class BFE Resistance (mmH20) Splash Resistance PFE
ASTM F 2100 Level 3 >99% < 6.0 160 mmHg >99%

🔹 Packing & Logistics

Packing Info
Packing Style QTY (pc) Carton Size (cm) G.W. (kg)
50pcs/box, 40boxes/ctn 200,000 52X40X36 8.5

🔹 Usage Instructions

How to wear:
  1. The dark side of the mask should be worn on the outside, while the light side should be close to the mouth.
  2. Shape the nose clip according to the bridge of the nose.
  3. Adjust the elastic loops for comfort.
How to remove:

Do not touch the front contaminated surface. Remove elastic bands from both ears and dispose of in a clinical waste container.

🔹 Related Products

Isolation Gown
Surgical Cap
Shoe Cover
Disposable Apron
Long Sleeve Apron
Bed Sheet

🔹 Frequently Asked Questions

1. What is the filtration efficiency of these surgical masks?
These masks offer a Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE) of ≥98% (and up to 99% for ASTM Level 3), providing high-level protection against pathogens and particles.
2. Are these masks compliant with international medical standards?
Yes, the masks are FDA 510K approved and CE certified. They meet ASTM F2100 Level 2 and Level 3 standards for medical-grade performance.
3. What materials are used in the construction of the 3-ply mask?
The mask consists of three layers: an inner and outer layer of polypropylene (PP) non-woven fabric and a middle layer of polypropylene (PP) melt-blown cloth for high filtration.
4. Can these masks resist fluid penetration?
Yes, these masks have synthetic blood penetration resistance ranging from 120 mmHg to 160 mmHg, making them suitable for surgical and hospital environments.
5. Are the earloops latex-free?
Yes, the masks are glass fiber-free and latex-free, designed to be skin-friendly and comfortable for long-term use without causing irritation.
6. What is the recommended application for these masks?
They are ideal for use in hospitals, surgeries, clinics, laboratories, and other medical environments where high-level respiratory and fluid protection is required.

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