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510(k) Data Aggregation

    K Number
    K023515
    Device Name
    PRE-POWDERED LATEX SURGEON'S GLOVES
    Manufacturer
    SANREA HEALTHCARE PRIVATE LIMITED
    Date Cleared
    2003-01-16

    (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 surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination

    Device Description

    pre-POWDERED LATEX SURGEON'S GLOVES

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Sanrea Healthcare Private Limited's "Pre-Powdered Latex Surgeon's Gloves." It does not contain information on acceptance criteria, study data, or AI-related performance. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This document is solely an FDA clearance for marketing the device based on substantial equivalence to a predicate device.

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