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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 glove is manufactured from nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand. The subject device is blue. The subject device is non-sterile, and single use device to prevent contamination between patient and examiner.

The subject device can be available in six specifications: XS、S、M、L、XL and XXL.

AI/ML Overview

This document is a 510(k) Premarket Notification for Nitrile Patient Examination Gloves, which are Class I devices. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not involve AI or complex medical imaging analysis. Therefore, many of the requested elements (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of medical device submission.

Here's an analysis of the provided text in the context of the requested information, focusing on what is relevant and explicitly stated:

Device: Nitrile Patient Examination Gloves (K211434)

This product is a simple, non-sterile, disposable examination glove. Its acceptance criteria and performance are based on established physical, chemical, and biocompatibility standards for such devices, not on complex algorithmic performance like AI.

1. Table of Acceptance Criteria and Reported Device Performance

The core of the performance evaluation is found in "Table 3 Performance Comparison" and the more detailed "Test Methodology" and "Results" table within Section 8.0 "Summary of Non-clinical Testing."

Item	Test Methodology	Acceptance Criteria	Reported Device Performance/Results
Physical Dimensions	ASTM D6319	Length (mm): XS/S: ≥220; M/L/XL: ≥230	Length: >230 (all sizes, meeting criteria)
		Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10; XXL: 130±10	XS: 78-80; S: 86-89; M: 97-99; L: 117-119; XL: 116-118; XXL: 128-131 (all Pass)
		Thickness (mm): Finger: ≥0.05; Palm: ≥0.05	Finger: 0.07-0.13 (Pass); Palm: 0.07-0.11 (Pass)
Physical Properties	ASTM D412	Before Aging: Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500%	Tensile Strength: 15.2-17.6 MPa (Pass); Ultimate Elongation: 520-579% (Pass)
		After Aging: Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400%	Tensile Strength: 15.3-17.5 MPa (Pass); Ultimate Elongation: 519-580% (Pass)
Freedom from Holes	ASTM D5151	AQL=2.5 (Be free from holes when tested)	2/125, 0/125, 0/125, 1/125, 0/125, 0/125 leaks (Pass)
Powder Content	ASTM D6124

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