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510(k) Data Aggregation

    K Number
    K213136
    Device Name
    CPL Surgical Face Mask
    Manufacturer
    Control Print Limited
    Date Cleared
    2021-12-24

    (88 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K203801
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The surgical face mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face masks are in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only, Available models: Surgical Face Mask EL (Ear loops) Surgical Face Mask TO (Tie-on)

    Device Description

    The CPL Surgical Face Mask is a 3-ply flat-pleated mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire 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 galvanized wire. The model Surgical Face Mask EL is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of braided elastic band. The model Surgical Face Mask TO is provided with non-woven tie-on string. The dimensions of the test item are: length- 175 ± 5 mm and width- 95 ± 5 mm. The ear loop length of the model Surgical Face Mask EL is 170± 5 mm. The tie-on of the model Surgical Face Mask TO has a top strap length of 410 ± 10 mm and bottom strap length of 385 ± 10 mm. The surgical masks are single-use, disposable devices, provided non-sterile.

    AI/ML Overview

    The document describes the acceptance criteria and the study conducted to demonstrate that the CPL Surgical Face Mask meets these criteria.

    Here's the information extracted from the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    No.Test PerformedAcceptance Criteria for Level 3 Classification (as per ASTM F2100 Requirements)Reported Performance (Surgical Face Mask EL)Reported Performance (Surgical Face Mask TO)Result
    1.Fluid resistance (ASTM F1862/F1862M-17)Pass at 160 mmHgPass at 160 mmHgPass at 160 mmHgPass
    2.Particulate Filtration Efficiency (PFE) (ASTM F2299 / F2299M - 03(2017))≥ 98%> 98%> 98%Pass
    3.Bacterial Filtration Efficiency (BFE) (ASTM F2101-19)≥ 98%> 98%> 98%Pass
    4.Differential pressure (ΔΡ) (EN 14683 (Annex C): 2019)
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