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    K Number
    K231446
    Device Name
    Single-Use Latex Sterile Surgical Gloves (SG100)
    Manufacturer
    Fitone Latex Products Co., Ltd. Guangdong
    Date Cleared
    2023-09-22

    (127 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K212848
    Why did this record match?
    Device Name :

    Single-Use Latex Sterile Surgical Gloves (SG100)

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

    The Single-Use Latex Sterile Surgical Gloves are device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    The proposed device, Single-Use Latex Sterile Surgical Gloves is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577- 09(15), the rubber surgical gloves classification is: Type 1-qloves compounded primarily from nature rubber latex." The qloves are powderfree and available in white in sizes 6, 6.5, 7, 7.5, 8, 8.5 and 9. The proposed device is provided Radiation sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The latex surgical glove shelf life is 3 years.

    AI/ML Overview

    This document is a 510(k) Pre-market Notification for a medical device, specifically Single-Use Latex Sterile Surgical Gloves (SG100). It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive study proving novel effectiveness.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document presents two tables relevant to acceptance criteria and device performance:

    Table 1: Comparison of Technological Characteristics (Proposed vs. Predicate) - This table indirectly shows performance against standards and similarities with the predicate.

    CharacteristicAcceptance criteria of the standard (Implied or Explicit)Proposed device K231446Predicate device K212848Remarks
    Product nameN/A (Comparison, not an acceptance criterion)Single-Use Latex Sterile Surgical GlovesSterile Latex Surgical Gloves Powder FreeSimilar
    Indications For UseN/A (Comparison, not an acceptance criterion)To protect surgical wound from contaminationTo protect surgical wound from contaminationSimilar
    Product CodeKGOKGOKGOSame
    Regulation Number21 CFR 878.446021 CFR 878.446021 CFR 878.4460Same
    Powdered or Powder freePowdered freePowdered freePowdered freeSame
    Classification as per ASTM D3577-2019Type I - gloves compounded primarily from natural rubber latexType I - gloves compounded primarily from natural rubber latexType I - gloves compounded primarily from natural rubber latexSame
    Type of useOver the counter useOver the counter useOver the counter useSame
    Shelf Life3 Years3 Years3 YearsSame
    SterilizationRadiation, SAL- 10-6Radiation, SAL- 10-6Radiation, SAL- 10-6Same
    Single useYesYesYesSame
    Label and LabelingMeet FDA's RequirementMeet FDA's RequirementMeet FDA's RequirementSame
    Protein ContentN/A (Comparison, predicate has a lower value, but both meet )
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