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510(k) Data Aggregation

    K Number
    K211536
    Device Name
    Welspun Health Surgical Mask
    Manufacturer
    Welspun India Limited
    Date Cleared
    2021-09-01

    (106 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K202511
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Welspun Health Surgical Mask, formatted as requested:

    1. A table of acceptance criteria and the reported device performance

    Test PerformedAcceptance Criteria (for Level 3 Classification as per ASTM F2100)Proposed Device Model No.: WHSM002ELB PerformanceProposed Device Model No.: WHSM002ELW PerformanceResult
    Fluid resistance (ASTM F1862/F1862M-17)29 out of 32 Pass at 160 mmHgPass at 160 mmHgPass at 160 mmHgPass
    Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03(2017))≥ 98%>99%>99%Pass
    Bacterial Filtration Efficiency (BFE) (ASTM F2101-19)≥ 98%>98%>98%Pass
    Differential pressure (ΔΡ) (EN 14683 (Annex C):2019)
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