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510(k) Data Aggregation
K Number
K232359Device Name
Surgical face mask
Manufacturer
Date Cleared
2023-10-02
(56 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Kingstar Medical (Xianning) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 is a single use, disposable device(s), provided non-sterile.
Device Description
The Surgical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the face mask is composed of 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 two elastic ear loops are welded to the face mask, can held the face mask in place over the users' mouth and nose. The elastic ear loops are made of Spandex and polyester, is not made with natural rubber latex.
The nose piece is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PP-Ferrum wire.
The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
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