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510(k) Data Aggregation
K Number
K210487Device Name
MIPLNI YK-244 Disposable Surgical Mask
Manufacturer
Date Cleared
2021-03-16
(25 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Hunan Yuankang Biological Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Surgical 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(s), provided non-sterile.
Device Description
The subject device is a Blue color and Flat Pleated type mask, utilizing the Ear Loops for wearing, and has Nose Piece design for fitting the facemask around the nose. The subject device 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 filters. The subject device is 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 contained in the subject device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of metal core plastic (aluminum metal core inside of polypropylene). The subject device is sold non-sterile and is intended to be single use, disposable device.
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