Buda-U Surgical Face Mask, 3 Layers Disposable Mask- China White List - Type IIR- 50

Key Specifications/Special Features:

• • BFE ≥98% , Non-Sterile, TYPE IIR ;
• • CE Certification, FDA Device Listed.
• • Providing Respiratory Protection in Hospital Operations Rooms, Clinics, Patient Care, Labor and Delivery, Infection Control Practices and Laboratory, Suitable for use when in outdoor activities,daily travel, public gatherings and school.
• • In conformity with EU Standard: EN 14683: 2019+ AC:2019
• • 3 Layers : Liquid-Proof Non-Woven Fabric for the Outer Layer, Meltblown in the Middle and Inner Skin-Friendly Layer;
• • Resistant to Fluid/Blood Penetration;
• • Good Breathability;
• • Firm, Elastic & Comfortable Earloops ;
• • MFG and EXP. Date Actively Printed on Packing Box ;

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Packing Specifications:

• Packed with Easy-to-draw Polybag in High quality Box

• 50 Pcs /Box , 2500Pcs / Carton, LWH: 52CM X 42CM X 42CM

Certifications and Qualifications:

Meeting All Requirements of EN 14683: 2019 + AC:2019; DOC

Competitive Advantage:

Manufacturing Date and Expiration Date are Actively Printed on the Box; BFE ≥ 98% or Above Filtration Efficiency;

In conformity with EU Standard; High Breathability ;

Total 3 LAYERS Protection; Skin Friendly Materials;

High Quality Packing Box; 50 Pcs / Box

Mfg. Date and Exp.Date Printed on Box 2500Pcs / Carton, LWH: 52CM X 42CM X 42CM

About the Microbial cleanliness (Bio-burden) of A Medical Face Mask:

The Bio-burden of a medical face Mask at EN 14683: 2019 Standard indicates the mask’s cleanliness. This means the mask production should be carried on in the dust-free workshop in order to assure the cleanliness. Further, the production team members should wear gloves , cap etc to avoid pollutions.

For medical face masks, when tested according to EN ISO 11737-1:2018 the bioburden of the medical mask shall be ≤ 30 CFU/g tested.

EN ISO 11737-1:2018 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material or package.

To Get More Information About the EU Medical Face Masks Standard

Download EU Medical Face Masks Standard : EN 14683 : 2019 + AC : 2019

DOWNLOAD

Tag

Medical Face Mask, Disposable Face Mask,disposable mask ,3PLY mask,3ply face mask, Face Mask, Medical mask, Dust mask,En14683 Mask,Medical device

 Buda-U is committed to producing Personal Protective Equipment (PPEs) and Medical Devices , including FFP2 Mask , FFP3 protective mask ( Filtering Half Mask Particulate Respirator) , KN95 Mask and 3ply Medical/Surgical Face Masks (Type II, Type IIR ) for adults and children. Buda-U is the brand of PURIFA Medical Dongguan China, and It is the mask exporter and manufacturer in China White List.

Buda-U’s main production base, in Dongguan, China, produces over 500K pieces of FFP2, FFP3, KN95 protective masks and over 500K pieces of 3ply Medical Face Mask and Surgical Face Masks per day. Our dust-free workshops run 24 hours a day in order to meet the increasing demand of protective products for our customers across the globe.