MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

• K Number: K982691
• Device Name: MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
• Manufacturer: PERUSAHAAN INTAN EMAS SDN. BHD.
• Date Cleared: 1998-10-09 ( 67 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Latex Examination Glove is a disposable medical device intended for medical handling purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the blood, other body fluids, mucous membranes, or non-intact skin of patient.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer the request as it pertains to a regulatory letter regarding the marketing of "Multi-Comfort Powdered Examination Gloves" and does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document discusses the substantial equivalence of the gloves to previously marketed devices and outlines regulatory compliance for manufacturing and labeling.

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.