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510(k) Data Aggregation

    K Number
    K021533
    Device Name
    DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
    Manufacturer
    CREATIVE CONTRACT (M) SDN BHD
    Date Cleared
    2003-03-05

    (299 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 :

    DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)

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

    DermAssist ™ Fluid Resistant Surgical Mask / Procedure Mask is a high filtration 3 ply face mask is intended to be worn by an operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms body fluids and particulate materials.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a surgical mask. It does not contain information about acceptance criteria or a study proving device performance in the way typically found for AI/ML powered medical devices. The clearance is based on substantial equivalence to a predicate device, not on specific performance metrics derived from a study like those described in your questions.

    Therefore, I cannot extract the requested information from the provided text. The questions you've asked are relevant for AI/ML devices, but this document pertains to a traditional medical device (a surgical mask).

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