Medical nitrile examination gloves (Model: JL001)

• K Number: K213848
• Device Name: Medical nitrile examination gloves (Model: JL001)
• Manufacturer: Guangdong Jiali Pharmaceutical Co.,Ltd
• Date Cleared: 2022-03-25 ( 105 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: K203593
• Predicate For: N/A

Intended Use

The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Device Description

The subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and has a rolled rim at the cuff edge.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Medical Nitrile Examination Gloves (Model: JL001), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Method	Test Purpose	Acceptance Criteria	Reported Device Performance	Conclusion
ASTM D6319-19 (Physical Dimensions)	To determine the width, length, and thickness of the gloves	Width:
For S: 80±10 mm
For M: 95±10 mm
For L: 110±10 mm
For XL: 120±10 mm
Length:
For S: ≥220mm
For M/L/XL: ≥230mm
Finger Thickness: min. 0.05 mm
Palm Thickness: min. 0.05 mm	Lot Batch 20210716A:
Width: S: 7983mm, M: 9397mm, L: 101-105mm, XL: 110mm
Length: S: 233237mm, M: 233237mm, L: 240244mm, XL: 240244mm
Thickness: Finger min: 0.12mm, Palm min: 0.08mm
Lot Batch 20210719A:
Width: S: 7983mm, M: 9497mm, L: 101-104mm, XL: 110mm
Length: S: 234236mm, M: 234237mm, L: 240244mm, XL: 240245mm
Thickness: Finger min: 0.13mm, Palm min: 0.08mm
Lot Batch 20210721C:
Width: S: 8085mm, M: 9498mm, L: 105-109mm, XL: 110mm
Length: S: 230235mm, M: 235238mm, L: 239243mm, XL: 240243mm
Thickness: Finger min: 0.13mm, Palm min: 0.08mm	Passed
ASTM D6319-19 (Physical Properties)	To determine the tensile strength and ultimate elongation before and after acceleration aging	Before Aging:
Tensile Strength: ≥14Mpa
Ultimate Elongation: ≥500%
After Aging:
Tensile Strength: ≥14Mpa
Ultimate Elongation: ≥400%	For all three lots:
Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500%
After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400%	Passed
ASTM D6319-19 (ASTM D5151-11) (Freedom from Holes)	To determine the holes in the gloves	AQL 2.5	For all three lots: Pass at AQL 2.5	Passed
ASTM D6319-19 (ASTM D6124-11) (Residual Powder)	To determine the residual powder in the gloves

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.