Disposable Nitrile Examination Glove

• K Number: K212661
• Device Name: Disposable Nitrile Examination Glove
• Manufacturer: Inner Mongolia Cureguard Medical Technology Co.,Ltd.
• Date Cleared: 2021-11-19 ( 88 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: K171422

Intended Use

The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

The subject device is powder free nitrile patient examination gloves. The subject device is white color. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Disposable Nitrile Examination Glove

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319	Physical Dimensions Test	Length (mm):
XS/S: ≥ 220;
M/L/XL: ≥ 230;
Width:
XS: 70±10;
S: 80±10;
M: 95±10;
L: 105±10;
XL: 115±10	Length (mm): >230 (all sizes)
Width (mm):
XS: 73-76;
S: 80-83
M: 95-97
L: 110-114
XL: 118-120
Pass
ASTM D6319	Thickness	Finger: ≥ 0.05 mm
Palm: ≥ 0.05 mm	XS:
Finger: 0.07-0.11 mm
Palm: 0.08-0.10 mm
S:
Finger: 0.08-0.10 mm
Palm: 0.08-0.11 mm
M:
Finger: 0.08-0.11 mm
Palm: 0.08-0.11 mm
L:
Finger: 0.08-0.12 mm
Palm: 0.09-0.12 mm
XL:
Finger: 0.08-0.12 mm
Palm: 0.08-0.11 mm
Pass
ASTM D5151	Watertightness Test for Holes	Meet the requirements of ASTM D5151 AQL 2.5	XS: 0/125 leaks
S: 0/125 leaks
M: 0/125 leaks
L: 1/125 leaks
XL: 1/125 leaks
Pass
ASTM D6124	Powder Content

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.