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510(k) Data Aggregation
K Number
K202277Device Name
Surgical Face Mask
Manufacturer
Date Cleared
2020-09-25
(45 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Jiangxi 3L Medical Products Group Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the 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(s), provided non-sterile.
Device Description
The surgical face mask is green color, and Flat Pleated type mask, utilizing Tie-On way for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical 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 a melt-blown polypropylene filter. The model of the proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spunbond polypropylene. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The surgical face masks are sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
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