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K Number
K102074
Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)
Manufacturer
GX CORPORATION SDN BHD
Date Cleared
2010-11-02

(99 days)

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

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.

Device Description

Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, Blue (SG).

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for "Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, Blue (SG)". This document describes the regulatory approval of a medical device (gloves) and not an AI or software device. Therefore, the requested information regarding acceptance criteria and studies for an AI/software device cannot be extracted from this document.

The document mainly focuses on:

  • The device being substantially equivalent to legally marketed predicate devices.
  • The regulation number, product code, and regulatory class of the device.
  • General controls provisions of the Act applicable to the device.
  • A list of chemotherapy drugs and the gloves' permeation (breakthrough detection time) for each.

There is no information about:

  1. AI acceptance criteria or device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies.
  6. Standalone (algorithm-only) performance.
  7. Type of ground truth used for AI.
  8. Training set sample size.
  9. Ground truth establishment for the training set.

§ 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.