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510(k) Data Aggregation
K Number
K211536Device Name
Welspun Health Surgical Mask
Manufacturer
Date Cleared
2021-09-01
(106 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Welspun India Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Welspun Health Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only.
Device Description
Welspun Health Surgical Mask is a surgical face mask identified by Regulation 21 CFR 878.4040 under FDA product code, FXX. This medical device is offered in two colors – medical blue (Model No.: WHSM002ELB) and white (Model No.: WHSM002ELW). The Welspun Health Surqical Mask is three-layer, flat pleated mask. It is made up of three layers of non-woven polypropylene on automatic mask making machine using the ultrasonic sealing technology. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The ear loops are made of round knitted elastic band. The nose strip contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene coated single core aluminium wire. The surgical masks are single-use, disposable devices, provided non-sterile.
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