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K Number
K990499
Device Name
PREPOWDERED NITRILE EXAMINATION GLOVES
Manufacturer
FLEXITECH SDN. BHD.
Date Cleared
1999-04-02

(44 days)

Product Code
LZA
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

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Pre-Powdered Nitrile Examination Gloves

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA to FLEXITECH SDN. BHD. regarding "Pre-Powdered Nitrile Examination Gloves." This is not a study document that describes acceptance criteria and device performance data.

Therefore, I cannot provide the requested information from this document. It does not contain details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is primarily an FDA clearance letter for a medical device (nitrile gloves) based on substantial equivalence to a predicate device, rather than a report detailing performance studies against specific acceptance criteria for an AI/algorithm-based 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.