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510(k) Data Aggregation

    K Number
    K030364
    Device Name
    DEROYAL GOWNS, STERILE, NON-STERILE
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Date Cleared
    2003-04-28

    (83 days)

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

    DEROYAL GOWNS, STERILE, NON-STERILE

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

    DeRoyal Gowns are surgical attire that is worn by operating room personnel to protect both operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate materials during surgical procedures.

    DeRoyal will receive the nonsterile gowns from the converter made to DeRoyal's specification and use them in Convenience Kits that are sterilized, market the nonsterile gowns to other OEM customers, and market sterile individually packaged gowns.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for DeRoyal Gowns. It states that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

    However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

    The document is purely an administrative letter granting market clearance based on substantial equivalence, and it explicitly states:

    "Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050."

    Therefore, I cannot fulfill your request for the specific information about acceptance criteria and study details based on the provided text. This information would typically be found in the 510(k) summary or the full premarket notification submission, which is not included here.

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