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510(k) Data Aggregation
K Number
K211631Device Name
Surgical Face Mask
Manufacturer
Macheng Thimble Technology Investment Co., Ltd
Date Cleared
2021-08-18
(83 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Macheng Thimble Technology Investment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 a single use, disposable device(s), provided non-sterile.
Device Description
The Surgical Face Masks are blue, flat pleated masks with ear loops to hold the device in place over the user's mouth and nose and a nose piece to fit the mask to the face. The proposed device(s) 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 polyester. They are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of face mask and is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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