POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)

• K Number: K993502
• Device Name: POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)
• Manufacturer: BESGLOVE MEDICARE SDN. BHD.
• Date Cleared: 1999-11-24 ( 40 days)
• Product Code: LYY
• 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 purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powderfree Latex Examination Gloves (Protein Label Claim) 50 MICROGRAMS OR LESS

AI/ML Overview

I'm sorry, but without further context, I cannot extract the specific acceptance criteria and detailed study information you're looking for. The provided text is a 510(k) clearance letter from the FDA, which confirms the substantial equivalence of Powderfree Latex Examination Gloves to a predicate device.

This document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on ground truth establishment, expert qualifications, or adjudication methods.
• Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The letter focuses on the regulatory clearance process for a medical device (gloves), not on a study proving a device meets specific technical performance criteria in the way you've outlined.

To provide the information you requested, I would need a different document, such as a clinical study report, a performance evaluation report, or a detailed technical specification document for a device that uses algorithms or requires complex performance analysis.

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.