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The Disposable Sterilized Latex Surgical Glove is a device made of nature rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, Disposable Sterilized Latex Surgical Gloves is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577-09(15), the rubber surgical gloves classification is: "Type 1-gloves compounded primarily from nature rubber latex." The gloves are powder-free and available in white in sizes 6, 6.5, 7, 7.5, 8, and 8.5. The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 106. The disposable sterilized latex surgical glove shelf life is 3 years.

This document is a 510(k) summary for Disposable Sterilized Latex Surgical Gloves, demonstrating substantial equivalence to a predicate device (K171550). It focuses on non-clinical performance data and does not involve AI or clinical studies as typically defined in medical imaging or diagnostic device contexts. Therefore, many of the requested points are not applicable.

Here's an analysis of the provided information in the context of the requested questions:

Acceptance Criteria and Device Performance

This product is a medical device (Disposable Sterilized Latex Surgical Gloves), not an AI algorithm. The "acceptance criteria" and "reported device performance" are based on physical, chemical, and biological properties of the gloves, compared against recognized ASTM and ISO standards.

Table of Acceptance Criteria and Reported Device Performance:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set:
  • For the Watertight test (ASTM D5151-19), the sample size was 200 pieces.
  • Other tests (e.g., dimensions, physical properties, residual powder, protein content, biocompatibility, sterilization residuals) refer to specific ASTM/ISO standards. While the standards themselves define sampling plans, the document does not explicitly state the exact sample size used for each of these specific tests beyond the watertight test.
• Data Provenance: The document does not specify the country of origin of the data (other than the manufacturer being in China) or whether the studies were retrospective or prospective. Given the nature of mechanical/chemical testing of medical devices, these are typically prospective laboratory tests conducted to specific standard protocols.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a medical device (surgical gloves) undergoing non-clinical performance and biocompatibility testing, not an AI algorithm requiring expert ground truthing of images or clinical data. The "ground truth" here is defined by physical, chemical, and biological measurement standards (ASTM, ISO, USP).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As above, this is non-clinical device testing, not a study involving human interpretation or consensus. The "adjudication" is based on meeting pre-defined numerical or qualitative criteria from recognized standards.

4. 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

• Not Applicable. This document pertains to the clearance of a physical medical device (surgical gloves), not an AI algorithm. Therefore, no MRMC study was conducted.

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

• Not Applicable. This document pertains to the clearance of a physical medical device (surgical gloves), not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical tests, the "ground truth" is defined by the established criteria within the cited ASTM, ISO, and USP standards. For example:
  • Dimensions are compared to specified minimums/ranges.
  • Tensile strength is compared to specified minimal MPa.
  • Watertightness is determined by meeting an AQL (Acceptance Quality Limit) of 1.5, meaning a certain percentage of defects is acceptable.
  • Biocompatibility (sensitization, irritation, systemic toxicity, pyrogenicity, endotoxin) is determined by standardized biological test methods with defined pass/fail criteria (e.g., "not a sensitizer," "not an irritant," "no systemic toxicity concern," "<20 EU/pair of gloves").
  • Protein and residual chemical content are compared to specified maximum limits.

7. The sample size for the training set

• Not Applicable. This is not an AI algorithm; there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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