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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 mmM: 95±10 mmL: 110±10 mmXL: 120±10 mmLength:S: ≥220 mmM/L/XL: ≥230 mm	Lot Batch 20210723C1:Width: S: 79-84mm, M: 93-97mm, L: 104-107mm, XL: 112-115mmLength: S: 231-235mm, M: 234-238mm, L: 237-240mm, XL: 238-243mmLot Batch 20210719A1:Width: S: 80-83mm, M: 93-96mm, L: 104-107mm, XL: 112-116mmLength: S: 231-235mm, M: 235-238mm, L: 237-240mm, XL: 239-243mmLot Batch 20210726A0:Width: S: 79-83mm, M: 94-97mm, L: 104-107mm, XL: 112-116mmLength: 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: ≥0.05mmPalm: ≥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: ≥14MpaUltimate Elongation: ≥500%After Aging:Tensile Strength: ≥14MpaUltimate 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	< 2.0 mg/glove	Lot Batch 20210723C1: 0.17 mg/gloveLot Batch 20210719A1: 0.23 mg/gloveLot Batch 20210726A0: 0.18 mg/glove	Passed (for all 3 lots)
ISO 10993-10 - Skin Irritation	To evaluate potential intracutaneous reactivity	Under the conditions of the study not an irritant	Under the conditions of study not an irritant	Passed
ISO 10993-10 - Skin Sensitization	To determine skin sensitization potential	Under the conditions of study not a sensitizer	Under the conditions of the study not a sensitizer	Passed
ISO 10993-11:2017 - Acute Systemic Toxicity	To evaluate for acute systemic toxicity	Under the conditions of the study no systemic toxicity	Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo.	Passed

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document refers to "Lot Batch of 20210723C1," "Lot Batch of 20210719A1," and "Lot Batch of 20210726A0" for physical dimensions, tensile strength, elongation, freedom from holes, and residual powder tests. While specific numbers of gloves per batch are not provided in this summary, the testing was done on multiple production lots.
Data Provenance: The manufacturing company, Jiangxi SanHao Medical Instruments Co.,Ltd, is located in China. The testing data would originate from their internal testing or qualified third-party labs, likely within China, as part of their manufacturing and quality control process. The nature of the testing is retrospective from manufactured batches to demonstrate compliance.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable: This is not an AI/SaMD study requiring expert interpretation of medical images or data. Ground truth for physical properties (e.g., dimensions, tensile strength) is established by standardized measurement methods according to ASTM and ISO standards, using calibrated equipment and trained technicians.

4. Adjudication Method for the Test Set

Not Applicable: As this involves physical and chemical property testing of gloves, adjudication methods typically used for expert disagreement in medical image interpretation are not relevant. Test results are objective measurements against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable: This is not an AI/SaMD study. No human readers or AI assistance for diagnostic tasks are involved.

6. Standalone Performance (AI algorithm only without human-in-the-loop performance)

Not Applicable: This is not an AI/SaMD device. The "device" is a physical medical glove. The performance presented is "standalone" in the sense that it is the performance of the physical product itself under various specified tests, without human decision-making assistance beyond standard testing procedures.

7. Type of Ground Truth Used

Objective Measurements against Standard Specifications: The ground truth for the device's performance is established by objective measurements (e.g., length in mm, tensile strength in MPa, powder content in mg/glove) that are compared against predefined numerical acceptance criteria specified in recognized industry standards (ASTM D6319-19, ASTM D5151-11, ASTM D6124-11, ISO 10993-10, ISO 10993-11). For biocompatibility, the ground truth is the biological response (e.g., "not an irritant," "not a sensitizer," "no systemic toxicity") observed in animal models, as per ISO standards.

8. Sample Size for the Training Set

Not Applicable: There is no "training set" in the context of device performance testing for a physical product like examination gloves. The manufacturing process is designed to consistently produce gloves meeting the specifications, and the tests are for verification/validation, not for training a model.

9. How the Ground Truth for the Training Set was Established

Not Applicable: As there is no training set for a physical product, this question is not relevant.

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