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
