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510(k) Data Aggregation
K Number
K210020Device Name
Medical Mask
Manufacturer
Date Cleared
2021-04-28
(114 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Zhende Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
Device Description
The Medical Masks are single use, three-layer, flat masks with ear loops/straps and nose clamp. The Medical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle laver is made of melt blown polvpropylene filter.
The model of proposed device, Ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The model of proposed device. Tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The nose clamp contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of metal core plastic.
The proposed devices are single use, disposable device, provided in both non-sterile and sterile forms.
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