Nitrile Examination Gloves, Green/ Blue/ Black Color

• K Number: K211778
• Device Name: Nitrile Examination Gloves, Green/ Blue/ Black Color
• Manufacturer: Zhenjiang SuHui Latex Products Co., Ltd.
• Date Cleared: 2021-09-02 ( 85 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: K171422
• Predicate For: N/A

Intended Use

The Nitrile Examination Gloves,Green/ Blue/ Black Color are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The subject device is powder free nitrile examination gloves. The subject device is provided in color Green, Blue or Black. The subject device is nonsterile.

AI/ML Overview

This document pertains to the 510(k) premarket notification for Nitrile Examination Gloves, Green/Blue/Black Color (K211778). The information provided describes the device, its intended use, and a comparison to a predicate device, focusing on non-clinical testing to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are detailed in the "Summary of Non-clinical Testing" section (page 7 onwards) and specifically in the table.

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319	Physical Dimensions Test	Length (mm): Blue/Green Color: XS/S: ≥220, M/L/XL: ≥230; Black: S: ≥220, M/L/XL: ≥230.
Width (mm): Blue/Green Color: XS:70±10; S:80±10; M:95±10; L:110±10; XL:120±10; Black Color: S:80±10; M:95±10; L:110±10; XL:120±10.
Thickness (mm): Finger: ≥0.05, Palm: ≥0.05.	Length: >230 mm (for all sizes, exceeding the minimums).
Width:

• Green Color: XS:7376; S:8084; M:9599; L:108111; XL:114~117.
• Blue Color: XS:7275; S:8590; M:9298; L:108111; XL:110~119.
• Black Color: S:8290; M:9397; L:108111; XL:114116.
  Thickness (mm):
• Green: Finger: 0.14-0.15, Palm: 0.12-0.14.
• Blue: Finger: 0.12-0.13, Palm: 0.11-0.12.
• Black: Finger: 0.15-0.16, Palm: 0.12-0.13.
  Result: Pass for all. |
  | ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 (Acceptable Quality Level of 2.5 for freedom from holes). | Green: 0/125 leaks; Blue: 0/125 leaks; Black: 0/125 leaks.
  Result: Pass for all. |
  | 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.