PURIFA Medical Production Co.,Ltd
| Payment Terms | T/T, EXW, FOB |
| Supply Ability | 200 K Pcs Per Day |
| Delivery Time | To Be Advised Based on Quantity |
| Packaging Details | 10 Pcs in a Polybag, 5 Polybags in a Box, 50 Pcs /Box , 2000 Pcs / Carton, LWH: 52cm x 36cm x 42cm, |
| Product name | Disposable Medical Face Mask, Kid's Face Mask, 3 Layers Protective Mask Blue Color |
| Color | Light Blue |
| Material | 3 Layers |
| Function | Respiratory Protection, Anti pollution,Suitable for use when in outdoor activities，daily travel, public gatherings and school. |
| Style | with earloops, Internal nose clip |
| Type | Breathable, Children Protective Mask, Skin friendly |
| Suitable age | 4-12 |
| Feature | 3 Ply, Breathable, Skin Care Materials |
| Standard | Medical Device Class I, BFE≥98% , EN14683+AC: 2019 |
| Size | 14.5 CM X 9.5 CM |
| Brand Name | Buda-U |
| Model Number | BU-CE50B |
| Certification | CE Certification, Regulations MDR, FDA Registration |
| Place of Origin | Dongguan, China |
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Product Specification
| Payment Terms | T/T, EXW, FOB | Supply Ability | 200 K Pcs Per Day |
| Delivery Time | To Be Advised Based on Quantity | Packaging Details | 10 Pcs in a Polybag, 5 Polybags in a Box, 50 Pcs /Box , 2000 Pcs / Carton, LWH: 52cm x 36cm x 42cm, |
| Product name | Disposable Medical Face Mask, Kid's Face Mask, 3 Layers Protective Mask Blue Color | Color | Light Blue |
| Material | 3 Layers | Function | Respiratory Protection, Anti pollution,Suitable for use when in outdoor activities，daily travel, public gatherings and school. |
| Style | with earloops, Internal nose clip | Type | Breathable, Children Protective Mask, Skin friendly |
| Suitable age | 4-12 | Feature | 3 Ply, Breathable, Skin Care Materials |
| Standard | Medical Device Class I, BFE≥98% , EN14683+AC: 2019 | Size | 14.5 CM X 9.5 CM |
| Brand Name | Buda-U | Model Number | BU-CE50B |
| Certification | CE Certification, Regulations MDR, FDA Registration | Place of Origin | Dongguan, China |
| High Light | MDR Disposable Medical Face Mask ，FDA Disposable Medical Face Mask ，Earloop Kids Face Mask 3 Layers | ||
Disposable Medical Face Mask, Kid's Face Mask, 3 Layers Protective Mask Blue Color
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
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
Face Mask, Disposable Face Mask, disposable mask , 3PLY mask,3ply face mask, Kid's Face Mask,Dust mask, EN14683 Mask, Medical device
Company Details
Business Type:
Manufacturer,Exporter,Seller
Year Established:
2020
Total Annual:
$7,000,000-$7,999,999
Employee Number:
100~149
Ecer Certification：
Verified Supplier
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 i... 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 i...
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