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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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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 Radiation 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 text describes the acceptance criteria and study results for "Sterile Latex Surgical Gloves Powder Free." Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for length, tensile strength, etc.). It refers to meeting the "acceptance criteria of the standard" (ASTM D3577-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D5712-15) which would define the sampling plans.

The data provenance is not explicitly stated as "country of origin" for the testing or whether it was retrospective/prospective. However, the applicant is "Pentavest Holdings Sdn Bhd" located in Melaka, Malaysia, suggesting the testing was performed, or overseen, with connections to Malaysia. The testing, described as "Bench tests," typically refers to laboratory-based evaluations of the device itself rather than clinical data from human subjects.

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)

This is not applicable to the submitted document. The "ground truth" for this medical device (Sterile Latex Surgical Gloves) is established through adherence to recognized international and national consensus standards (e.g., ASTM, ISO, USP) for physical, chemical, and biological properties, not by expert consensus in diagnostic imaging or clinical assessment. The standards themselves define the acceptable parameters.

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

Not applicable. This type of adjudication method is used in studies where human readers interpret data, such as medical images. For device performance testing against manufacturing and performance standards, the results are quantitative and compared directly to specified limits.

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 document pertains to the regulatory submission for surgical gloves, not an AI-powered diagnostic device.

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

Not applicable. This document is for surgical gloves, not an algorithm or AI device.

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

The "ground truth" for the device's performance is based on established consensus standards (ASTM, ISO, USP). These standards define the acceptable physical, chemical, and biological properties and performance characteristics for rubber surgical gloves. Compliance with these standards serves as the evidence that the device is safe and effective for its intended use.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth for it to be established.

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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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