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K Number
K013254
Device Name
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Manufacturer
TOP QUALITY MFG., INC.
Date Cleared
2002-02-04

(129 days)

Product Code
LZA,LYY
Regulation Number
880.6250
Type
Traditional
Panel
HO
Reference & Predicate Devices
K004018
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Top Quality Skingard Polycoat Powdered Latex Examination Glove with Aloe Vera is intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powdered Latex Examination Glove with Aloe Vera

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, specifically a "Powdered Latex Examination Glove with Aloe Vera." The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material properties and intended use. There is no information regarding AI/ML device performance, human reader studies, or ground truth establishment relevant to AI/ML.

Therefore, the following information is not available in the provided text:

  • A table of acceptance criteria and reported device performance (for an AI/ML device).
  • Sample size used for the test set and data provenance (for an AI/ML device).
  • Number of experts used to establish ground truth for the test set and their qualifications.
  • Adjudication method for the test set.
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
  • If a standalone (algorithm only without human-in-the-loop performance) study was done.
  • The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
  • The sample size for the training set (for an AI/ML device).
  • How the ground truth for the training set was established (for an AI/ML device).

The document is a 510(k) submission for a physical medical product (gloves), not an AI/ML powered device, and thus does not contain the type of information requested regarding AI/ML device performance and validation studies.

§ 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.