POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)

• K Number: K984020
• Device Name: POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
• Manufacturer: KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
• Date Cleared: 1998-12-23 ( 41 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

Powdered Latex Patient Examination Glove with protein content labeling claim (150 µg/g glove or less)

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for a powdered latex examination glove, and it does not contain information about acceptance criteria, study details, or performance data for a device as requested in your prompt. The letter only states that the device is substantially equivalent to legally marketed predicate devices.

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.