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510(k) Data Aggregation
K Number
K210767Device Name
Surgical Masks, Model:FE-1
Manufacturer
Date Cleared
2021-06-10
(87 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Hunan Triplex Precision Medical Devices 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.
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 Medical Procedure Masks are manufactured with three layers. The outer layer is made of double spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer which contacts with face is made of double spun-bonded polypropylene (PP) non-woven fabric. The Surgical Masks are single use, disposable device, provided non-sterile.
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