Nitrile Patient Examination Gloves

• K Number: K211012
• Device Name: Nitrile Patient Examination Gloves
• Manufacturer: Huayuan Medical Technology(Shangqiu) Co., Ltd.
• Date Cleared: 2021-07-23 ( 109 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: K171422
• Predicate For: N/A

Intended Use

The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

The subject device is powder free nitrile examination gloves. The subject device is cobalt blue. The subject device is non-sterile.

AI/ML Overview

This document describes the acceptance criteria and the study that proves the device meets those criteria for Nitrile Patient Examination Gloves (K211012).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319	Physical Dimensions Test	Length (mm): ≥230	Length: >230 mm (Pass)
		Width (mm):
XS: 80±10
S: 90±10
M: 100±10
L: 110±10
XL: 115±10
XXL: 125±10	Width (mm):
XS: 83-88
S: 90-94
M: 96-100
L: 109-114
XL: 117-121
XXL: 123-126 (Pass)
		Thickness (mm):
Finger: ≥0.05
Palm: ≥0.05	Thickness (mm):
XS: Finger: 0.08-0.10, Palm: 0.08-0.10
S: Finger: 0.07-0.11, Palm: 0.08-0.11
M: Finger: 0.08-0.12, Palm: 0.07-0.11
L: Finger: 0.08-0.13, Palm: 0.08-0.11
XL: Finger: 0.08-0.12, Palm: 0.08-0.13
XXL: Finger: 0.08-0.12, Palm: 0.08-0.13 (Pass)
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	XS: 0/125 leaks
S: 1/125 leaks
M: 0/125 leaks
L: 0/125 leaks
XL: 0/125 leaks
XXL: 1/125 leaks (Pass)
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124

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.