POWDERED LATEX EXAMINATION GLOVES

• K Number: K071323
• Device Name: POWDERED LATEX EXAMINATION GLOVES
• Manufacturer: QUALITY GALLANT SDN. BHD.
• Date Cleared: 2007-06-22 ( 43 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination purpos patient and examiner.

Device Description

POWDERED LATEX EXMAINATION GLOVES

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding "Powdered Latex Examination Gloves." This document primarily addresses regulatory approval and does not contain the detailed technical study information typically found in a device's performance evaluation.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text. The document confirms market clearance based on substantial equivalence to a predicate device, but it does not include performance data, ground truth establishment, sample sizes, or expert adjudication methods.

Summary of what cannot be provided from the given text:

1. Table of acceptance criteria and reported device performance: Not present. The letter is a regulatory approval, not a performance report.
2. Sample size for the test set and data provenance: Not present.
3. Number of experts and qualifications for ground truth: Not present.
4. Adjudication method for the test set: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable or present. This device is a physical glove, not an AI or imaging device where MRMC studies are common.
6. Standalone (algorithm only) performance information: Not applicable or present.
7. Type of ground truth used: Not applicable or present.
8. Sample size for the training set: Not applicable or present.
9. How ground truth for the training set was established: Not applicable or present.

Regulation Number and Section

§ 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.