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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 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 -09(2015), 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 method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.

The provided document is a 510(k) Premarket Notification for a medical device: "Sterile Latex Surgical Gloves powder free." This document focuses on demonstrating substantial equivalence to an existing predicate device, rather than proving the device meets clinical acceptance criteria for an AI/ML medical device. Therefore, many of the requested points related to AI/ML study design (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training set) are not applicable to this type of submission.

However, the document does contain information about performance testing against established standards, which serve as the acceptance criteria for this specific device.

Here's an analysis of the provided information, addressing the relevant points and noting those that are not applicable:

Device Name: Sterile Latex Surgical Gloves powder free
Submission Type: 510(k) Premarket Notification (for substantial equivalence)

1. A table of acceptance criteria and the reported device performance

The document provides extensive tables comparing the subject device's performance to the predicate device and against the specifications outlined in relevant ASTM standards. These standards define the "acceptance criteria" for the physical and chemical properties of surgical gloves.

Summary Table of Acceptance Criteria and Reported Performance (Selected Key Parameters)

Note on Biocompatibility (Cytotoxicity): The device reported "Cytotoxic" against an acceptance criteria of "non-cytotoxic." However, the comparison table in Section G.c notes that the predicate device (K192328) also tested "Cytotoxic" for this parameter. This indicates that while the specific test result might seem like a failure in isolation, in the context of demonstrating substantial equivalence to a legally marketed predicate, it is acceptable if the predicate device exhibits the same characteristic and is already on the market. The FDA would have cleared the predicate with this characteristic, implying it's acceptable for surgical gloves.

Study that proves the device meets the acceptance criteria:

The document describes non-clinical bench testing conducted to verify that the proposed device meets design specifications and acceptance criteria outlined in various industry standards (primarily ASTM and ISO).

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

• Sample Size: The document does not explicitly state the sample size for each test performed. However, the tests are performed according to recognized international standards (ASTM, ISO, USP), which typically specify minimum sample sizes for reliable results. For example, ASTM D5151-06 (Detection of Holes in Medical Gloves) employs an Acceptable Quality Level (AQL) methodology, implying a statistically determined sample size tested for pinholes.
• Data Provenance: The tests were conducted to support a 510(k) submission for a manufacturer in Malaysia (Aspen Glove Sdn. Bhd.). The data itself is "bench test" data. It is not patient data, so "retrospective or prospective" does not apply in the typical sense of a clinical study.

3. 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 not a study involving expert readers or establishment of ground truth by human experts, as it is a physical device (surgical glove) and not an AI/ML diagnostic tool. The "ground truth" here is defined by the technical specifications and test methods within the referenced ASTM and ISO standards.

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

• Not Applicable. This is a physical device performance study, not an imaging or diagnostic study requiring adjudication of expert opinions.

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

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

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

• The "ground truth" in this context is the established technical and performance specifications defined by international consensus standards (ASTM D3577-09, ASTM D5151-06, ASTM D6124-06, ISO 10993 series, USP). These standards outline the physical and chemical properties and safety requirements for such medical devices, and the tests verify compliance with these objective measures.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device and thus does not have a "training set."

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

• Not Applicable. As there is no training set for this type of device, ground truth establishment for a training set is irrelevant.

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