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510(k) Data Aggregation
K Number
K202628Device Name
Disposable Medical Face Mask
Date Cleared
2021-03-19
(189 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Qinghai Zhong Dao Win-win Medical Protective Equipment Co.,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This is a single use, disposable device(s), provided non-sterile.
Device Description
The Disposable Medical Face Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Disposable Medical Face Masks are manufactured with three layers. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric with blue color. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric with white color. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile.
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