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A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, Sterile Latex Surgical Gloves Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile 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, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes. All variants share the same natural color (No Color is added). The proposed device is sterilized using Gamma and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for Sterile Latex Surgical Gloves Powder Free (K212596), intended to be worn in operating rooms. The study is a non-clinical performance (bench testing) study demonstrating substantial equivalence to a predicate device (K192328).

Here's the breakdown of the information requested, based on the provided document:

Acceptance Criteria and Device Performance Study for Sterile Latex Surgical Gloves Powder Free (K212596)

The study performed is a non-clinical performance (bench testing) study, as explicitly stated under "SUMMARY OF NONCLINICAL PERFORMANCE DATA" and "SUMMARY OF CLINICAL PERFORMANCE DATA: Clinical data was not required for this submission." This type of study focuses on technical and physical characteristics rather than performance in a clinical setting with human participants.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally based on ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves, and other specific standards for each test.

Note on Cytotoxicity: The specific call out for "in vitro cytotoxicity" in the detailed results table (page 9) states "Under the conditions of the study cytotoxic." However, the acceptance criteria listed immediately above it is "Under the conditions of study non cytotoxic." And in the "Technological Characteristics Comparison" table (page 7), both the subject and predicate devices are listed as "cytotoxic" with an acceptance criterion of "cytotoxic" but then the standard states "non-cytotoxic." This is a discrepancy that would typically require clarification in a regulatory submission. Assuming the manufacturer has demonstrated that this level of cytotoxicity is acceptable for the intended use and does not pose a safety risk, or that the "acceptance criteria" presented in the detailed result is actually just reporting the finding, it passed. However, simply stating "cytotoxic" when the standard implies "non-cytotoxic" needs careful review. For the purpose of this summary, it's listed as reported.

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

• Sample Size: The document does not explicitly state the exact sample sizes (number of gloves) used for each bench test. Standards like ASTM D3577 typically specify sampling plans (e.g., AQL levels for defect testing).
• Data Provenance: The tests were conducted internally by the manufacturer or by contracted labs. The manufacturer is Amazing Rubber Products Pvt. Ltd. located in Kerala, India. The data is retrospective in the sense that it was collected as part of the device development and verification process to support the 510(k) submission.

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

• This information is not applicable as the study is a bench test verification of physical and chemical properties against established industry standards (e.g., ASTM, ISO, USP). Ground truth in this context is defined by these measurable standards and the associated testing methodologies, not by expert interpretation of, for example, medical images.

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

• This information is not applicable as the study is a bench test verification. Adjudication methods are typically used in clinical studies, especially those involving human interpretation (e.g., radiology reads) to resolve discrepancies.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices where human performance is being evaluated or improved with AI assistance. The device in question is a surgical glove, which is a physical product, not a diagnostic tool requiring human reader interpretation.

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

• No, this is not applicable. The device is a physical product (surgical glove), not an algorithm or AI system. Its performance is assessed through bench testing against established performance standards.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for this device is defined by established international and national standards and specifications for surgical gloves (e.g., ASTM D3577-2019, ISO 10993 series, USP monographs). These standards specify the acceptable physical, chemical, and biological properties through defined test methods.

8. The sample size for the training set

• Not applicable. This question pertains to machine learning models. The device is a physical product, not an AI/ML model that requires training.

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

• Not applicable. As above, this pertains to machine learning models.

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