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510(k) Data Aggregation
K Number
K202714Device Name
Medical Face Mask
Manufacturer
Date Cleared
2021-06-11
(268 days)
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Chongqing Chaoke Industry Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medical Face Mask is 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
The Medical Face Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. The Medical Face 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 by two elastic ear loops welded to the facemask. The elastic ear loops are 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 Galvanized iron wire+ Polyethylene(PE). The medical face masks will be provided in blue. The medical face masks are sold non-sterile and are intended to be single use, disposable devices.
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