LATEX EXAMINATION GLOVES

• K Number: K980215
• Device Name: LATEX EXAMINATION GLOVES
• Manufacturer: P.T. WANTONG INDUSTRY
• Date Cleared: 1998-03-13 ( 51 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Patient Examination Gloves

A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

LATEX EXAMINATION GLOVES, Powdered

AI/ML Overview

I am sorry, but the provided text does not contain the information requested. The document is a 510(k) clearance letter from the FDA for latex examination gloves and does not include details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications related to device performance.

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.