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510(k) Data Aggregation

    K Number
    K101103
    Device Name
    POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1
    Manufacturer
    BEST PUTRA GLOVES SDN BHD
    Date Cleared
    2010-07-16

    (87 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A BPG powdered latex surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This excludes the lubricating or dusting powder used in the glove.

    Device Description

    Powdered, Latex Surgical Glove

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a Powdered Latex Surgical Glove. It is a regulatory approval document and does not contain any information about a study or acceptance criteria related to a medical AI/ML device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, or MRMC comparative effectiveness studies because this document pertains to a physical medical device (surgical gloves), not an AI/ML system.

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