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510(k) Data Aggregation
K Number
K203646Device Name
Disposable Medical Face Mask
Date Cleared
2021-04-22
(129 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Mei Yi Kang Medical Technology CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable 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. This face mask is intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile.
Device Description
The Disposable Medical Face Mark is blue color, and flat pleated type mask, utilizing ear loops or tie-on way for wearing, and has nose strip design for fitting the facemask around the nose. The colorant used in the mask outer layer is blue: Copper phthalocyanine/ CAS number: 147-14-8). The proposed device is manufactured with three layers, the inner and outer layers made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model DY 96, tie-on, is held in place over the user's mouth and nose by four straps welded to the facemask. The straps are made of Spun-bond polypropylene. Its dimension is 17.5x9.5cm, strap is 38 cm, nose strip is 9.5±0.5 cm.
The models MK-34, DY 95 and DY 97, ear loops, are held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and Spandex, not made with natural rubber latex. The dimension of MK-34 is 14.5x9.5cm, ear loop is 13cm, nose strip is 9.5±0.5 cm. The dimension of DY 95 and DY 97 is 17.5x9.5cm, ear loop is 13 cm, nose strip is 9.5±0.5 cm.
The nose strip contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and galvanized iron wire.
The device is sold non-sterile and are intended to be single use, disposable device.
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