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K Number
K973871
Device Name
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)
Manufacturer
HARTALEGA SDN BHD
Date Cleared
1997-12-11

(62 days)

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

The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Powdered Latex Examination Gloves with Protein Content Labeling Claim of 100 micrograms or less.

AI/ML Overview

The provided text is a 510(k) approval letter from the FDA for "Latex Powdered Examination Gloves w/Protein Content Labeling Claim of 100 Micrograms or less". However, it does not contain specific details about acceptance criteria, device performance tables, sample sizes, expert qualifications, or study methodologies that are typically found in a clinical study report or a more detailed submission document.

This document is a regulatory approval, stating that the device is substantially equivalent to a predicate device and can be marketed. It refers to the "indications for use" and general regulatory compliance.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample sizes used for the test set or data provenance.
  3. Number of experts used or their qualifications for ground truth.
  4. Adjudication method.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
  6. Information about a standalone (algorithm only) performance study.
  7. The type of ground truth used (expert consensus, pathology, etc.).
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

§ 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.