Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)

• K Number: K211620
• Device Name: Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
• Manufacturer: Shen Wei USA Inc.
• Date Cleared: 2021-08-19 ( 85 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Biodegradable Powder Free Latex Examination Gloves" and discusses regulatory compliance, not performance studies of a specific AI device. Therefore, I cannot generate the requested table and study details.

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.