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A 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.

Powder Free Nitrile Examination Glove - Blue, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. 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.

This document is a 510(k) Premarket Notification from the FDA for a Powder Free Nitrile Examination Glove. It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of acceptance criteria and the reported device performance

The relevant table is "Table 1" and the "Summary of Non-Clinical Testing" section. They outline the acceptance criteria, primarily based on ASTM standards, and the performance of the device and the predicate device.

The "Comparison Analysis" column in Table 1 notes that some characteristics (Tensile Strength, Ultimate Elongation, Thickness, Powder Free) are "Different but within the ASTM standard," indicating they meet the acceptance criteria despite not being identical to the predicate device.

2. Sample sized used for the test set and the data provenance

• Physical Properties (Tensile Strength, Elongation): Sample size is not explicitly stated for these tests within the provided text, but it commonly involves multiple samples to determine average values. The data provenance is implied to be from Hong Seng Gloves Sdn Bhd, Malaysia, as they are the submitter and manufacturer. This is retrospective testing done by the manufacturer to demonstrate compliance.
• Watertight:
  • Sample size: 500 pieces were tested. The batch size for this sampling was 150,001 to 500,000, and according to the single sampling plan G1, the sample drawn was code M equivalent to 315 pieces, but 500 pcs were tested.
  • Data Provenance: From the manufacturer (Hong Seng Gloves Sdn Bhd, Malaysia), as part of their non-clinical testing. This is retrospective testing.
• Powder Free:
  • Sample size: 5 pieces (as stated in the "Summary of Non-Clinical Testing" table under "Results" for Powder Free).
  • Data Provenance: From the manufacturer (Hong Seng Gloves Sdn Bhd, Malaysia). Retrospective testing.
• Dimension:
  • Sample size: Not explicitly stated for each size, but dimension measurements would typically involve multiple gloves per size.
  • Data Provenance: From the manufacturer (Hong Seng Gloves Sdn Bhd, Malaysia). Retrospective testing.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity): Sample sizes for biological tests (e.g., number of animals for irritation/sensitization, cell cultures for cytotoxicity) are not specified, but the tests were performed "under the conditions of the study" and passed relevant ISO standards.
  • Data Provenance: These are specified as being performed according to ISO standards, implying accredited lab testing, likely commissioned by the manufacturer. Retrospective testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document describes a 510(k) submission for a Class I medical device (examination glove). The ground truth for this type of device is established through performance against recognized industry standards (e.g., ASTM, ISO).

• No human "experts" in the sense of clinicians or radiologists are used to establish ground truth for performance testing in this context. The ground truth is objective, quantifiable measurements against pre-defined engineering and safety standards.
• Therefore, the concepts of "number of experts" and "qualifications of those experts" (like radiologists with 10 years of experience) are not applicable to the non-clinical performance testing described here.

4. Adjudication method

• As the ground truth is established by objective measurements against ASTM/ISO standards, there is no adjudication method (like 2+1 or 3+1 consensus) required for these types of tests. The results are quantitative and directly compared to the numerical acceptance criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was performed. This device is a physical examination glove, not an AI-powered diagnostic tool or an imaging device. The concept of "human readers improving with AI assistance" is entirely irrelevant to this product submission.
• The document explicitly states: "No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is an examination glove, not an algorithm. There is no "algorithm only" performance to evaluate.

7. The type of ground truth used

• The ground truth used for this device's performance evaluation is based on established national and international consensus standards for physical properties and biocompatibility of medical gloves, specifically:
  • ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application
  • ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves
  • ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves
  • ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (presumably variations are used for physical properties before/after aging)
  • ASTM D3767: Standard Practice for Rubber--Measurement of Dimensions
  • ISO 10993-10:2010 (E): Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
  • ISO 10993-5:2009 (E): Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-11:2017 (E): Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
  • Medical Glove Guidance Manual – Labeling

8. The sample size for the training set

• Not applicable. This submission is for a physical medical device (a glove) and does not involve AI or machine learning algorithms that require a "training set." The testing outlined is for product quality and safety validation, not algorithm development.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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