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K Number
K983334
Device Name
NITRILE POWDER FREE EXAMINATION GLOVES
Manufacturer
CRANBERRY (M) SDN. BHD.
Date Cleared
1999-02-19

(149 days)

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

This product is a patient examination glove. It 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.

Device Description

Nitrile Powder Free Examination Glove - Cranberry

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for Nitrile Powder-Free Examination Gloves. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of the requested AI/medical device study information.

The document indicates that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It pertains to a physical medical device (examination gloves) and not an AI/software as a medical device.

Therefore, I cannot provide the requested information such as:

  1. A table of acceptance criteria and the reported device performance: Not applicable, as this is a physical device clearance based on substantial equivalence, not performance metrics against specific criteria.
  2. Sample size used for the test set and the data provenance: Not applicable.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
  6. If a standalone performance was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 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.