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510(k) Data Aggregation
K Number
K202137Device Name
Disposable medical mask
Manufacturer
Date Cleared
2021-03-04
(216 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
U-Play Products Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable 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. This is a single use, disposable device(s), provided non-sterile.
Device Description
Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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 which are welded to the facemask. There are two types of ear loops for the disposable medical masks, one shaped in thin rope is made of Nylon and spandex, and the other shaped in narrow band is made of spun-bond polypropylene and elastic body. The ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polypropylene coating with iron wire. The medical masks will be provided in blue. The medical masks are sold non-sterile and are intended to be single use, disposable devices.
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