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Dongguan Meiao Medical Device Technology Co., Ltd

Dongguan Meiao Medical Device Technology Co., Ltd

3450812976@qq.com

86-137-12023644

Dongguan Meiao Medical Device Technology Co., Ltd
HomeProductsFace MaskAdult MaskFolding Disposable Mask/One time folding kf94 mask

Folding Disposable Mask/One time folding kf94 mask

  • $100
    ≥1000
    Box
Payment Type:
Private account / public account
Min. Order:
1000 Box
Transportation:
Ocean,Land,Air,Express
Port:
Humen Port,Guancheng port area,Shilong port area
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  • Product Description
Overview
Product Attributes

Model No.meiao159

Supply Ability & Additional Informations

PackagingMask box

TransportationOcean,Land,Air,Express

Supply AbilityNissan: 3 million

PortHumen Port,Guancheng port area,Shilong port area

Payment TypePrivate account / public account

Packaging & Delivery
Selling Units:
Box
Package Type:
Mask box
Picture Example:

The regulatory agency for medical masks in the United States is FDA. In the FDA system, there are three classification codes for masks. One is a Surgical Mask, one is a pediatric kf94mask, and the other is a surgical mask with antibacterial / antiviral agents.
The masks in the FDA classification database all belong to rule 878.4040, and are classified as class II. They all need to apply for 510k approval. So the way we normally export the kf94mask to the United States is:
1) Conduct product testing (performance test, biological test)
2) Prepare 510k documents and submit them to FDA for review
3) FDA sends 510k approval letter
4) Complete plant registration and device listing
5) Export of products

Kf94 maskKf94 maskKf94 maskKf94 maskKf94 maskKf94 maskKf94 mask


Product Categories : Face Mask > Adult Mask

Company Overview

Dongguan Mayo Medical Technology Co., Ltd. was established in 2020. Located at Room301,Unit 2, No.4 Dongxin 2 Road, Humen Town, Dongguan City, Guangdon Province, it is a modern enterprise mainly engaged in the medical devices and personal protective equipment. It is also a comprehensive enterprise of R&D, production and marketing with total investment about 20 million.

Covering an area of 1200 M²,it is a dust-free workshop and will be equipped with 10 latest full automated KN95 respirator production lines, and it is estimated that after all production lines are working steadily, the amount of daily output for KN95 respirators would reach 500,000 pcs.

Our products are under application of BSI standard Module B and Module D certification. According to the EUA issued by the US FDA, the certification is also currently underway, as well as NIOSH certification. We have completed a foreign trade operator for the record, and the customs import and export for the record, in addition to the first Ⅱ class medical apparatus and instruments for the record is also carried out in sync.

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