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510(k) Data Aggregation

    K Number
    K250735
    Device Name
    Dental Barrier and Sleeves
    Manufacturer
    Fomed Industries, Inc.
    Date Cleared
    2025-06-10

    (91 days)

    Product Code
    PEM
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fomed Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K220512
    Device Name
    Disposable Surgical Face Mask (M01, M02)
    Manufacturer
    Fomed Industries Inc.
    Date Cleared
    2022-04-25

    (62 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K210433
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fomed Industries Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Surgical Face 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 Disposable Surgical Face Mask is blue color, single use, that-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.

    The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of galvanized iron wire coated by polypropylene (PP), ear loop is made of Nylon and Spandex, and the ties are made of polypropylene spun-bond nonwoven fabric.

    The size of surgical face masks is 17.5*9.5cm with tolerance±5%, the length of the ear loop is about 15.5cm to 16.5cm, and the length of the ties is 40 cm.

    The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    The provided document is a 510(k) summary for a Disposable Surgical Face Mask. This type of medical device is generally subject to performance testing against established standards, rather than clinical studies requiring expert interpretation or AI/algorithm performance. Therefore, many of the requested elements (like MRMC studies, details on experts, ground truth for training sets, etc.) are not applicable to this specific device submission.

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The device is a non-powered, non-software-driven medical device (disposable surgical face mask). Its performance is evaluated against recognized industry standards for surgical masks.

    Test MethodologyPurposeAcceptance Criteria (ASTM F2100 Level 3)Reported Device Performance
    Fluid Resistance (ASTM F1862)To assess resistance to penetration by synthetic blood.29 out of 32 pass at 160 mmHg for level 3Pass: 32 out of 32 pass at 160 mmHg, 3 lots
    Particulate Filtration Efficiency (ASTM F2299)To demonstrate functionality and efficiency of materials in filtering particulates.≥ 98%Pass: Average 99.1%
    Bacterial Filtration Efficiency (ASTM F2101)To demonstrate functionality and efficiency in filtering bacteria.≥ 98%Pass: Average 99.5%
    Differential Pressure (EN 14683 Annex C)To measure breathability.
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