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510(k) Data Aggregation
K Number
K210815Device Name
Disposable Face Mask
Manufacturer
Date Cleared
2021-05-13
(56 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Biobase Scientific (Shandong) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Face 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. This is a single use, disposable device, provided non-sterile.
Device Description
The Disposable Face Mask is single use, three-layer, flat-pleated mask with ear loops and nose clip. The inner and outer layers of the mask are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene. The ear loops are held in place over the users' mouth and nose by two elastic ear straps. The ear loops are made of spandex and nylon. The nose clip is a malleable iron wire covered by polyethylene. Users can adjust the nose clip according to the shape of the nose and fix the mask on the bridge of the nose to prevent the mask from falling off. The Disposable Face Mask is blue and provided non-sterile.
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