POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM

• K Number: K011563
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM
• Manufacturer: U.O.P. RUBBER PRODUCTS SDN BHD
• Date Cleared: 2001-06-05 ( 15 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 gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient.

Device Description

POWDER FREE LATEX EXAMINATION GLOVES. WITH WATER EXTRACTABLE PROTEIN LABELLING CLAI

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA to U.O.P. Rubber Products Sdn Bhd regarding their "Powder Free Latex Examination Gloves with Water Extractable Protein Labeling Claim." This document confirms the substantial equivalence of the device to legally marketed predicate devices.

However, the document does not contain information about:

1. Specific acceptance criteria or reported device performance metrics in a table.
2. Details of any study (e.g., sample sizes, data provenance, expert qualifications, adjudication methods) that would establish the device meets performance criteria for AI/ML.
3. Multi-reader multi-case (MRMC) comparative effectiveness studies.
4. Standalone algorithm performance studies.
5. Type of ground truth used in such studies.
6. Training set sample size or how its ground truth was established.

This type of FDA letter focuses on the regulatory clearance process for a relatively standard medical device (examination gloves) based on substantial equivalence, rather than a detailed performance study for an AI/ML-driven device. The "Indication For Use" attachment clarifies the intended use of the gloves but does not delve into performance metrics or study designs for AI.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is not present in the 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.