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510(k) Data Aggregation
K Number
K211552Device Name
Surgical mask
Manufacturer
Date Cleared
2021-08-11
(84 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Shandong Shengquan New Materials Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 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 surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, and provided non-sterile.
Device Description
The Surgical Mask is a non-sterile, single use, and flat pleated mask with ear loops and nose clip. The product is manufactured with three layers, the inner layer is made of white polypropylene spunbond, the outer layer is made of black polypropylene spunbond (a common colorant named carbon black was added) and the middle layer is made of melt blown polypropylene filter. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The mask will be provided in black and white. The colour of outer layer is black. The colour of inner layer is white.
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