LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

• K Number: K111158
• Device Name: LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
• Manufacturer: INNOVATIVE GLOVES CO; LTD
• Date Cleared: 2011-08-10 ( 107 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A powder-free patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner

Device Description

Latex Examination Gloves Powder-Free (Black Color) and with protein content labeling claim(50 micrograms or less)

AI/ML Overview

This document is a 510(k) premarket notification determination letter from the FDA for "Latex Examination Gloves Powder-Free (Black Color) and with Protein Content Labeling Claim (50 micrograms or less)". It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity.

Instead, the letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the new device is as safe and effective as a previously cleared device. The "acceptance criteria" in this context would primarily pertain to compliance with FDA regulations, good manufacturing practices, and performance characteristics (like protein content, physical properties such as tensile strength and elongation, and freedom from holes) that demonstrate substantial equivalence to predicate devices, rather than a statistical study proving clinical performance of an AI/ML diagnostic tool.

Therefore, I cannot provide the requested information from the provided text as it is not present in this type of FDA document.

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.