SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM

• K Number: K021059
• Device Name: SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
• Manufacturer: SYNTEX HEALTHCARE PRODUCTS CO. LTD.
• Date Cleared: 2002-05-14 ( 42 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Description

Powder-Free Latex Examination Glove with Protein Labeling Claim ( 50 Micrograms or Less )

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Powder-Free Latex Examination Glove with Protein Labeling Claim (50 Micrograms or Less).

Unfortunately, this type of document is not relevant to the request of describing acceptance criteria and a study proving a device meets those criteria for an AI/ML medical device.

Here's why:

• Device Type: This document pertains to a physical medical device (examination gloves), not an AI/ML software device.
• Regulatory Pathway: The 510(k) pathway for traditional medical devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through performance testing on physical attributes (e.g., tensile strength, barrier integrity, protein content for allergies). It does not typically involve the kinds of clinical performance studies (e.g., diagnostic accuracy, sensitivity, specificity) that are foundational to AI/ML device evaluations.
• Missing Information: The letter itself only confirms the clearance and does not detail the specific test methods, acceptance criteria, or study designs used to support the substantial equivalence claim for the glove. It references a "Protein Labeling Claim," implying tests were done for protein content, but no specifics are provided.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document as it simply isn't present or relevant to an AI/ML context.

To provide the requested information, I would need a document that describes the clinical validation or performance study for an AI/ML-based medical device.

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.