POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

• K Number: K101841
• Device Name: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
• Manufacturer: SHIJIAZHUANG SAIL PLASTIC CO., LTD.
• Date Cleared: 2010-07-16 ( 15 days)
• Product Code: LYZ
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: K032907
• Predicate For: N/A

Intended Use

Powdered vinyl 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 vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

AI/ML Overview

Here's an analysis of the provided information regarding the device's acceptance criteria and the study demonstrating its compliance:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Standard (Acceptance Criteria)	Device Performance (Reported)
Dimension	ASTM standard D 5250-06	Meets
Physical Properties	ASTM standard D 5250-06	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Amount	ASTM standard D 5250-06

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.