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510(k) Data Aggregation

    K Number
    K201182
    Device Name
    iMask Disposable Surgical Face Mask
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2021-02-19

    (294 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    iMask Disposable Surgical Face Mask

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

    The iMask 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 intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided nonsterile.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA for a disposable surgical face mask. It does not contain information about acceptance criteria or a study proving that an AI/ML powered device meets those criteria. The questions posed in the prompt are relevant to AI/ML powered medical devices, but this document describes a physical medical device (a face mask) and its regulatory clearance.

    Therefore, I cannot extract the requested information from this document.

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