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The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content, that meets all of the requirements of ASTM standard D3578-91.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

   • Watertight test: "S-4, AQL 4.0" and "AQL of 2.5" relate to sampling plans (e.g., ISO 2859-1 or MIL-STD-105E). While the exact sample size isn't explicitly stated, these AQL levels imply a statistically determined sample size for lot release testing based on batch quantity.
   • Clinical data (Modified Draize test): 200 human subjects.
   • Data Provence: Not explicitly stated, but the manufacturer is Wembley Rubber Products (M) Sdn Bhd in Selangor, Malaysia, suggesting the testing was likely conducted in Malaysia or a related region, or according to international standards. The data is retrospective for the purpose of this 510(k) submission.

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

   • For the physical and chemical property tests (watertight, length, width, thickness, tensile strength, elongation, powder, and protein content), the "ground truth" is established by the specifications defined in ASTM D 3578-91 and FDA 1000 ml watertight test. These are standardized tests with objective measurements, not typically requiring individual expert consensus for ground truth but rather adherence to validated testing methodologies by qualified technicians.
   • For the Modified Draize test, the "ground truth" regarding dermal irritation or sensitization is established by the clinical assessment of the 200 human subjects by qualified personnel (e.g., dermatologists or clinical researchers experienced in dermatological assessments). The number and specific qualifications of these experts are not detailed in the provided text.

4. Adjudication method for the test set:

   • For the physical and chemical tests, adjudication is not typically used as the tests yield objective, quantitative results against defined criteria. A "pass" or "fail" is determined directly by measurement against the standard.
   • For the Modified Draize test, the determination of "no potential for eliciting either dermal irritation or sensitization" would be based on the assessment of the clinical researchers overseeing the study. The specific adjudication method (e.g., blind assessment, multiple reader agreement) is not specified.

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, this document pertains to the performance testing of a physical medical device (examination gloves), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

   • Not applicable. This is for a physical medical device.

7. The type of ground truth used:

   • For physical and chemical properties: Objective criteria defined by recognized standards (ASTM D 3578-91) and regulatory requirements (FDA 1000 ml watertight test).
   • For hypoallergenic claim: Clinical outcomes data from a Modified Draize test on 200 human subjects (dermal irritation and sensitization results).

8. The sample size for the training set:

   • Not applicable. This document describes performance testing of a manufactured product against standards, not the development or training of an algorithm.

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

   • Not applicable.

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