CE Certification En14683 Type Iir Disposable Medical Face Mask

• Customization: Available
• Standard: GB19083-2010
• Filter Rating: Bfe99% or Bfe95%
• Model NO.: WELLMIEN-FM0020
• Available Times: Disposable
• Type: Medical Surgical Mask
• Layers: 3 Ply
• Style: Earloop
• Shape: Flat
• Sterilization: Sterilization
• Age Group: Adult
• Color: White, Green, Blue ..
• Size: 17.5*9.5cm
• Function: Protection for Operation
• Classify: Bfe 99% 3ply Ear-Loop Pleated Surgical Face Mask
• Application: Hospital, Medical, Dental, Daily Use
• Material: Non-woven Fabric
• Certification: CE, FDA, ISO13485
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Group: Adult
• Logo Printing: With Logo Printing
• Quality Guarantee Period: Five Years
• Transport Package: 50PCS/Box, 40boxes
• Specification: CE, ISO13485
• Trademark: WELLMIEN OR OEM
• Origin: Jiangsu
• HS Code: 6307900090
• Production Capacity: 6, 000, 000 Pieces / Month

Product Description

EN14683 Type IIR Disposable Medical Face Mask - 3-Ply Surgical Mask with CE Certification, Fluid-Resistant, BFE ≥ 98%

Detailed Photos

Product Description

Parameters

Attribute	Details
Product Name	EN14683 Type IIR Disposable Medical Face Mask
Standard Compliance	EN14683:2019 Type IIR (European Standard)
Material	Nonwoven Polypropylene (3-ply)
Layers	Outer hydrophobic layer, Melt-blown filter, Inner soft layer
Bacterial Filtration Efficiency (BFE)	≥ 98%
Fluid Resistance	≥ 120 mmHg (splash-resistant)
Breathability (ΔP)	< 60 Pa/cm²
Microbial Cleanliness	≤ 30 CFU/g
Flammability	Class 1
Color Options	Blue, White, Pink, Green (customizable)
Size	17.5 x 9.5 cm (adult)
Earloop	Elastic, latex-free
Nose Clip	Adjustable aluminum strip
Sterility	Non-sterile
Certifications	CE Marked, EN14683:2019, ISO13485
Packaging	50 pcs/box, 2000 pcs/carton (OEM packaging available)
Shelf Life	2 years
Usage	Single-use, Disposable

Features:

• Certified Type IIR Mask:
  Complies with EN14683:2019 standards for medical masks with high bacterial filtration and fluid resistance, making it ideal for surgical use.

• 3-Layer Protection:
  Combines a splash-resistant outer layer, a high-efficiency melt-blown filter, and a soft inner layer for maximum safety and comfort.

• Fluid-Resistant (120 mmHg):
  Protects against splashes and sprays of blood and bodily fluids in medical environments.

• High BFE ≥ 98%:
  Filters out bacteria and airborne particles to protect both the wearer and others.

• Comfortable Fit:
  Features elastic earloops and a flexible nose strip for a secure, comfortable seal without slipping.

• Hypoallergenic & Latex-Free:
  Safe for all skin types, including sensitive users.

Quality Control:
1. We will not start to make the products until you confirm the sample.
2. The packing will be water-proof, damp-proof and sealed.
 

Standard Class	Bacterial Filtration Efficiency(BFE)	Breathing Resistance(mmH20/cm2)	Splash Resistance(mmHg)
Type I	>98%	<3.0	N/A
Type IR	>98%	<5.0	120
Type II	>99%	<3.0	N/A
Type IIR	>99%	<5.0	120

Our Advantages

Our Advantage:

1. CE, ISO13485 certification.
2. One-stop service: Excellent disposable medical products, personal protection equipments.
3. Welcome any OEM requirements.
4. Qualified products, 100% new brand material, safe and sanitary.
5. Offered free samples.
6. Professional shipping service if necessary.
7. Full series after sales service system.

Sample Policy:
Factory direct sale new breathing mask Protective masks general face mask
1. Sample according to your design drawing. Sampling time: 3-5days.
2. Design your own sample, then remake it.
3. Existing Samples Sampling time: 1day
4. Make mass production after your confirm the sample.

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