POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES

• K Number: K092100
• Device Name: POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
• Manufacturer: TANGSHAN HONGXING PLASTIC PRODUCTS CO., LTD.
• Date Cleared: 2009-09-18 ( 66 days)
• Product Code: LYZ
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Device Description

Patient Vinyl Examination Gloves, PowderFree, Non-Sterile

AI/ML Overview

This document is an FDA 510(k) clearance letter for "Patient Vinyl Examination Gloves, PowderFree, Non-Sterile." It explicitly states that the device is substantially equivalent to legally marketed predicate devices and does not require approval of a Premarket Approval Application (PMA).

However, the provided text does not contain any information about acceptance criteria, a study, or performance data for the device. The letter is an administrative notification of clearance based on equivalence, not a detailed report of a device's performance against specific criteria.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set.
• Data provenance for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method.
• Whether an MRMC comparative effectiveness study was done or its effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

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.