Blue Disposable Medical Face Mask , Earloop MDR Kids Face Mask 3 Layers

Disposable Medical Face Mask, Kid's Face Mask, 3 Layers Protective Mask Blue Color

Key Specifications/Special Features:

• • BFE≥≥98%, Type II Level ,Color: Light Blue
• • 14.5 CM X 9.5 CM , Suitable for Age 4-12;
• • In conformity with EU Standard: EN 14683: 2019 + AC:2019
• • CE , FDA Device Listed and Registration
• • 3 Layers : Liquid-Proof Non-Woven Fabric for the Outer Layer, Meltblown in the Middle and Inner Skin-Friendly Layer;
• • Low Breathing Resistance, Good Wearing Experience;
• • Firm, Elastic & Comfortable Earloops ;
• • Packing Box with Different Global EAN Barcodes;
• • MFG and EXP. Date Actively Printed on Packing Box ;
• • Manufactured in Dust-free workshop ;

Packing Specifications:

• 10 Pcs in a Polybag, 5 Polybags in a Box;
• 50 Pcs /Box , 2000 Pcs / Carton, LWH: 52cm x 36cm x 42cm,

Competitive Advantage:

BFE ≥ 98% or Above Filtration Efficiency; In conformity with EU Standard, MDR Regulations

10 Pcs in a Pack, 5 Packs / Box; 50 Pcs / Box; Suitable for Age 4-12

Total 3 LAYERS Protection; Elastic and Firm Earloops; Skin Friendly Materials;

High Quality Packing Materials, Packing Cartons ;2000 Pcs / Carton

Certifications and Qualifications:

CE

China CCCMHPIE White List

Buda-U Certifications and Qualifications

• Buda-U is the USA FDA EUA Authorized Respirator Manufacturer;

• FDA Device Listed and Registration.

• In China CCCMHPIE White List.

• Buda-U FFP2, FFP3 Protective Masks have got the CE certification by Spanish NB CE 0370 ( Module B+C2 certification)

• 3ply Disposable Medical/Surgical Masks for both Children and Adults have conducted the Attestation of Conformity and meet all the requirements of the EU medical standard of EN 14683: 2019+ AC 2019, and are in conformity with the new provisions of MDR Regulations.

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.

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:

Face Mask, Disposable Face Mask, disposable mask , 3PLY mask,3ply face mask, Kid's Face Mask,Dust mask, EN14683 Mask, Medical device