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510(k) Data Aggregation

    K Number
    K021076
    Device Name
    PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-04-16

    (13 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K001951
    Why did this record match?
    Device Name :

    PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP

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

    Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for surgical masks. It does not contain information on acceptance criteria or a study proving that a device meets such criteria in the manner requested (i.e. for an AI-powered medical device).

    Therefore, I cannot provide the detailed information requested in the prompt based on the provided text. The document pertains to a traditional medical device (surgical mask) and its substantial equivalence to a predicate device, not an AI/ML-based device requiring a study with acceptance criteria as described.

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