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Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

The provided text describes the acceptance criteria and performance data for the "Penta Glove," a Blue Nitrile Examination Glove. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a legally marketed predicate device rather than undergoing a de novo approval process.

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

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes for each individual test. However, it references ASTM and ISO standards for the testing. These standards typically outline the required sample sizes for performing such tests (e.g., number of gloves per batch for AQL, number of animals for biocompatibility).

• Data Provenance: The testing appears to be conducted by the manufacturer or a contracted lab to meet international standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993 series, USP 42). The submitter, Pentavest Holdings Sdn Bhd, is located in Malaysia. Thus, the data provenance is likely from Malaysia or other regions where these standard tests are performed. The data is prospective for the device being submitted, as these tests would have been performed on samples of the Penta Glove specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the document describes the testing of a medical device (examination gloves) based on objective, standardized measurements and laboratory tests (e.g., tensile strength, dimensions, chemical residue, cytotoxicity, etc.). These tests rely on equipment and technical procedures to generate quantifiable results, not expert consensus or interpretation of subjective images/data. Therefore, there's no "ground truth" established by experts in the typical sense of clinical or diagnostic studies.

4. Adjudication Method for the Test Set:

This is not applicable. As mentioned above, the tests are objective measurements and laboratory analyses, not human interpretation requiring adjudication. Results are compared against predefined numerical or qualitative acceptance criteria specified in the relevant standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This is not applicable. The device is an examination glove, a physical medical device. It is not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable for the same reason as point 5. The device is a physical glove, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these tests is based on objective, quantitative measurements and established international standards (ASTM, ISO, USP). For example:

• Dimensions: Measured values compared to specified minimums/ranges.
• Physical Properties: Measured tensile strength and elongation compared to minimum requirements.
• Water Tightness: Tested against an Acceptable Quality Level (AQL) specification (e.g., 1.5).
• Residual Powder: Measured mass of powder per glove compared to a maximum limit.
• Biocompatibility: In-vitro or in-vivo biological responses (e.g., irritation, sensitization, cytotoxicity, systemic toxicity, endotoxin levels) are observed and compared against predefined criteria for biological safety (e.g., "not an irritant," "not a sensitizer," "non cytotoxic," "do not pose a systemic toxicity concern," "NMT 20 EU/pair").

8. The Sample Size for the Training Set:

This is not applicable. The Penta Glove is a physical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the same reason as point 8.

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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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