STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED

• K Number: K062778
• Device Name: STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
• Manufacturer: WEAR SAFE MALAYSIA SDN. BHD.
• Date Cleared: 2006-10-27 ( 39 days)
• Product Code: LZA , LYZ
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: 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 between patient and examiner.

Device Description

Sterile Powder-Free Nitrile Patient Examination Glove, Blue Colored,
Non-sterile Powder-free Nitrile Patient Examination Glove, Blue Colored,

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA for a medical device: "Sterile Powder-Free Nitrile Patient Examination Glove, Blue" and "Non-Sterile Powder-Free Nitrile Patient Examination Glove, Blue." This type of document does not contain the detailed acceptance criteria or the study that proves the device meets those criteria in the way described in the request.

A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device. The letter confirms that the FDA has reviewed the submission and found the device substantially equivalent for its intended use. It does not provide performance study details.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document confirms market clearance based on substantial equivalence, but it does not detail:

1. A table of acceptance criteria or 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 for a test set.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This information would typically be found in the actual 510(k) submission, specifically sections related to performance data, or in a separate clinical study report, not in the FDA's clearance letter.

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.