POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE

• K Number: K983721
• Device Name: POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE
• Manufacturer: KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
• Date Cleared: 1998-12-07 ( 46 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 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.

Device Description

Polymer-Coated, Powder-Free, Latex Patient Examination Glove

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding a Polymer-Coated, Powder-Free, Latex Patient Examination Glove. This document approves the market entry of a medical device and therefore, does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document discusses:

• The FDA's review and determination of substantial equivalence for the device.
• The regulatory classification of the device (Class I).
• General controls provisions of the Act that apply to the device.
• Contact information for further inquiries regarding labeling regulations and promotion/advertising.
• The intended use of the device: "A 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."

To answer your specific questions, information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment would typically be found in the 510(k) submission document itself, not in the FDA's response letter. The FDA letter is a confirmation of clearance based on the information provided in the submission.

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.