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The Medical nitrile examination gloves (Model: SH001) 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, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface with textured fingertips and a rolled rim at the cuff edge. The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for "Medical nitrile examination gloves (Model: SH001)" to demonstrate substantial equivalence to a predicate device for FDA 510(k) clearance. This is a Class I medical device and the data provided is for non-clinical performance testing, primarily mechanical and biocompatibility tests, not an AI/Software-as-a-Medical-Device (SaMD) study.

Therefore, many of the requested items related to AI/SaMD studies (e.g., human-in-the-loop performance, expert ground truth, adjudication methods, multi-reader multi-case studies, training/test set sample sizes for AI, etc.) are not applicable to this submission focusing on physical product characteristics of examination gloves.

I will provide the information that is applicable from the provided text.

Acceptance Criteria and Device Performance for Medical Nitrile Examination Gloves (Model: SH001)

The device, Medical nitrile examination gloves (Model: SH001), underwent non-clinical performance testing to demonstrate its safety and effectiveness, primarily adhering to the ASTM D6319-19 standard. The study aimed to show substantial equivalence to a predicate device (K203593).

1. Table of Acceptance Criteria and Reported Device Performance

Test Method (Standard)	Test Purpose	Acceptance Criteria	Reported Device Performance (Test Results)	Conclusion
ASTM D6319-19 - Physical Dimensions Test	To determine the width, length, and thickness of the gloves	Width:
S: 80±10 mm
M: 95±10 mm
L: 110±10 mm
XL: 120±10 mm
Length:
S: ≥220 mm
M/L/XL: ≥230 mm	Lot Batch 20210723C1:
Width: S: 79-84mm, M: 93-97mm, L: 104-107mm, XL: 112-115mm
Length: S: 231-235mm, M: 234-238mm, L: 237-240mm, XL: 238-243mm
Lot Batch 20210719A1:
Width: S: 80-83mm, M: 93-96mm, L: 104-107mm, XL: 112-116mm
Length: S: 231-235mm, M: 235-238mm, L: 237-240mm, XL: 239-243mm
Lot Batch 20210726A0:
Width: S: 79-83mm, M: 94-97mm, L: 104-107mm, XL: 112-116mm
Length: S: 232-235mm, M: 235-238mm, L: 237-240mm, XL: 238-243mm	Passed (for all 3 lots)
ASTM D6319-19 - Thickness Test	To determine the thickness of the gloves	Finger: ≥0.05mm
Palm: ≥0.05mm	For all three lots (S/M/L/XL): Finger min: 0.13mm, Palm min: 0.13mm	Passed (for all 3 lots)
ASTM D6319-19 - Physical Properties (Tensile Strength & Ultimate Elongation)	To determine tensile strength and ultimate elongation before and after accelerated 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 (for all 3 lots)
ASTM D6319-19 (ASTM D5151-11) - Freedom from Holes (Water Tight)	To determine the holes in the gloves	AQL 2.5	For all three lots: Pass at AQL 2.5	Passed (for all 3 lots)
ASTM D6319-19 (ASTM D6124-11) - Residual Powder	To determine the residual powder in the gloves

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