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K Number
K990840
Device Name
NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
Manufacturer
TERANG NUSA SDN BHD
Date Cleared
1999-05-17

(63 days)

Product Code
LZA
Regulation Number
880.6250
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The examination gloves are to be worn by healthcare workers or similar personnel during work to prevent cross contamination between the user and the patient.

Device Description

Nugard Nitril meet the requirement for examination glove described by the American Standard for Testing and Material ASTM D 3578 with the exception of ultimate elongation before aging. It is blue in color. Sizes available is from XS - XL

AI/ML Overview

The provided document is a 510(k) summary for the NUGARD Powderfree Nitrile Examination Glove, not a study report for an AI/ML device. Therefore, it does not contain information typically found in a study proving a device meets acceptance criteria for such technologies.

The document discusses the regulatory submission for a medical glove, focusing on its substantial equivalence to a predicate device and its compliance with ASTM standards. As such, it does not involve the components of an AI/ML device study.

Here's a breakdown of why the requested information cannot be provided from the given text:

  1. Acceptance Criteria and Reported Device Performance (Table): The document states the device "meet the requirement for examination glove described by the American Standard for Testing and Material ASTM D 3578 with the exception of ultimate elongation before aging." It also mentions "Biocompatibility tests are carried out." However, specific numerical acceptance criteria (e.g., AQL levels for pinholes) and detailed reported performance values (e.g., tensile strength, elongation at break) are not provided in this summary.

  2. Sample size, Data Provenance (for test set), Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth (test set), Training Set Sample Size, Training Set Ground Truth:
    These items are all related to studies for AI/ML devices or diagnostic tools where ground truth needs to be established and validated. This document is for a physical medical device (examination glove) and does not involve AI/ML algorithms, image analysis, or diagnostic predictions.

    • There is no "test set" in the context of an AI/ML device for a medical glove.
    • No "experts" were used to establish ground truth for image/data interpretation.
    • No "adjudication method" is relevant.
    • No "MRMC comparative effectiveness study" was done as there's no AI to assist human readers.
    • No "standalone algorithm performance" is applicable.
    • The "ground truth" for a glove would be its physical properties meeting ASTM standards.
    • No "training set" for an algorithm exists.

In summary, the provided text describes a regulatory submission for a medical glove, where compliance with existing ASTM standards and biocompatibility tests are the primary methods of demonstrating safety and effectiveness. It does not provide the type of information requested for evaluating an AI/ML medical device.

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.