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510(k) Data Aggregation
K Number
K222809Device Name
Medical Disposable Face Masks
Manufacturer
Date Cleared
2023-01-03
(109 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Anqing Mayfield Medical Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medical Disposable Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is 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 nonsterile.
Device Description
The Medical Disposable Face Mask is blue color, single use, three-layer, flat-pleated mask with nose piece and ear loop. The blue colorant is polypropylene (PP) masterbatch. The Medical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of polyester and spandex, not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable aluminum with polypropylene (PP) covering. Users can adjust the nose piece according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The medical face masks are available in two size specifications, 17.5×9.5cm, 14.5×9.5cm. The medical face masks are sold non-sterile and are intended to be single use, disposable devices.
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