POWDERED VINYL EXAMINATION GLOVE

• K Number: K983893
• Device Name: POWDERED VINYL EXAMINATION GLOVE
• Manufacturer: SHIJIAZHUANG BRETHERN PLASTIC CO.,LTD.
• Date Cleared: 1999-06-21 ( 231 days)
• Product Code: LYZ
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Device Description

Powdered Vinyl Examination Gloves

AI/ML Overview

I am sorry, but based on the provided document, there is no information about the acceptance criteria or a study proving the device meets those criteria.

This document is a 510(k) clearance letter from the FDA for "Powdered Vinyl Examination Gloves" manufactured by Shijiazhuang Brethren Plastic Company, Limited. It indicates that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

The letter discusses regulatory aspects like general controls, GMP compliance, and labeling, and includes an "Indication For Use Statement." However, it does not contain:

1. A table of acceptance criteria or reported device performance.
2. Details about sample size, data provenance, or ground truth establishment for a test set.
3. Information on expert involvement or adjudication methods.
4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
5. Information on a training set or how its ground truth was established.

The document's purpose is to grant market clearance based on substantial equivalence, not to detail the specific performance testing data that supported that equivalence.

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.