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510(k) Data Aggregation
K Number
K202358Device Name
Protective Face Mask for Medical Use
Manufacturer
Date Cleared
2021-01-29
(163 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Hunan Heng Chang Pharmaceutical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the 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/sterile.
Device Description
The Protective Face Masks for Medical Use are flat-folded masks are three layers of materials consisting of polypropylene spun-bond (outer layer and inner layer), polypropylene melt-blown (middle layers). The masks contain a conformable nose piece enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, elastic ear loops not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in white. The Protective Face Masks for Medical Use are single use, disposable device, provided non-sterile/sterile.
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K Number
K202354Device Name
Surgical Mask-Model Number CW01
Manufacturer
Date Cleared
2020-09-08
(20 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Hunan Heng Chang Pharmaceutical 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 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/ sterile.
Device Description
The Surgical 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 Face Masks are manufactured with three layers. The outer layer is made of spunbonded polypropylene (PP) non-woven fabric. 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 polypropylene (PP) fabric. The Surgical Masks are single use, disposable device, provided non-sterile/sterile.
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