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510(k) Data Aggregation
K Number
K202761Device Name
Medical Surgical Mask (Non-sterile)
Date Cleared
2021-04-11
(202 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Guangdong GoodFeeling Hygiene Material Tec Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The medical surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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 proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric. The model of the proposed device, ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of knitted elastic loops (made of nylon and spandex). The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is a galvanized wire with polyethylene covering. The proposed device is provided non-sterile and is intended to be a single use, disposable device.
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