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510(k) Data Aggregation
K Number
K223055Device Name
Disposable Medical Face Mask
Manufacturer
Xiantao Zhuobo Industrial Co., LTD
Date Cleared
2022-12-05
(67 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xiantao Zhuobo Industrial Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Medical Face Mask is intended to be worn to protect 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
Disposable Medical Face Mask is a blue flat-pleated mask, which is worn in the way of earrings and has a nose clip design to fit the mask around the nose. This product is composed of a mask body (three-layer structure: two layers of polypropylene adhesive nonwoven fabric with a layer of polypropylene melt-blown nonwoven fabric in the middle), a nose clip (made of polyethylene) and ear loops (made of polyester + spandex). The nose clip is located in the middle layer of the mask. Ear loops, string-like material, are attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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