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K Number
K140050
Device Name
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
Manufacturer
HARTALEGA SDN BHD
Date Cleared
2014-09-12

(246 days)

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

The Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination betwreen patient and examiner.

The Nittile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) and Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue)

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for medical examination gloves and does not contain information about acceptance criteria or a study proving that an AI/device meets acceptance criteria. It pertains to a physical medical device (examination gloves), not a software or AI-driven device.

Therefore, I cannot provide the requested information based on the input text. There is no mention of:

  • Acceptance criteria for an AI or software device.
  • A study proving a device meets acceptance criteria.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Experts used to establish ground truth or their qualifications.
  • Adjudication methods.
  • MRMC comparative effectiveness studies.
  • Standalone algorithm performance.
  • Types of ground truth.
  • How ground truth for a training set was established.

The document is an FDA letter granting substantial equivalence to "Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU)" and "Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue)".

§ 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.