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Powder Free White Nitrile Examination Gloves, Non-Sterile is a disposable device and made of Synthetic Rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Powder Free White Nitrile Examination Gloves, Non sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.

This document describes the acceptance criteria and performance of Powder Free White Nitrile Examination Gloves, Non-Sterile.

1. Table of Acceptance Criteria and Reported Device Performance:

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Powder Free Nitrile Examination Gloves, Blue, Non-Sterile is a disposable device and made of Synthetic Rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.

Here's an analysis of the acceptance criteria and study information for the device, based on the provided text:

Device: Powder Free Nitrile Examination Gloves, Blue, Non-Sterile

1. Table of Acceptance Criteria and Reported Device Performance:

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Powder Free Latex Examination Gloves, Blue, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.

The provided text describes the acceptance criteria and performance of Powder Free Latex Examination Gloves. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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Latex Examination Gloves, Powdered, Blue, Non-Sterile is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Latex Examination Gloves, Powdered, Blue, Non Sterile meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.

The provided document describes the acceptance criteria and performance of PT. WRP Buana Multicorpora's Latex Examination Gloves, Powdered, Blue, Non-Sterile.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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The Powder Free Latex Examination Gloves, Non-Sterile (Protein Content Labeling 50 µg/g or less) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling 50 ug/q or less) is Class I Device, Code No. 80LYY. These gloves are made of natural rubber latex. Based on the protein content test result obtained the aloves are well bellow 50 ug/g and support our protein content labeling claim.

The provided text describes a 510(k) summary for "Glovetex Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50ug/g or less)". This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study on a new device's performance against detailed acceptance criteria for an AI/algorithm.

The "acceptance criteria" and "device performance" in this context refer to the physical and chemical properties of the gloves themselves, compared against established standards for examination gloves and the specific protein content claim. The "study" described is the testing conducted on the gloves to demonstrate conformance to these standards and the protein content claim.

Here's an attempt to structure the information based on the provided request, interpreting "acceptance criteria" and "device performance" in the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for each specific test (e.g., protein content, ASTM D 3578, water leak test). It generally states that "The result of the performance testing... are detailed in this submission."

• Sample Size: Not explicitly stated for the test set of gloves.
• Data Provenance: The manufacturing company is PT. WRP Buana Multicorpora, located in Indonesia. The testing would have been conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but performance testing for a 510(k) submission typically involves prospective testing of production samples.

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

This type of information (number of experts, their qualifications, and ground truth establishment) is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis). For the physical and chemical testing of examination gloves, "ground truth" is established by laboratory measurements and adherence to specified testing protocols (e.g., ASTM standards). Therefore, this question is not directly applicable in the conventional sense to this device. The "experts" would be qualified laboratory technicians or engineers performing the tests.

4. Adjudication Method for the Test Set

Again, adjudication methods like 2+1 or 3+1 are primarily used for reaching consensus among multiple human reviewers/experts, particularly in studies involving subjective interpretation. For objective laboratory tests on gloves, adjudication is not typically performed in this manner. The results are based on direct measurement and comparison to predefined thresholds.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or interpretive devices (e.g., AI in radiology) where human readers are involved. This submission is for physical examination gloves.

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

No, this pertains to a physical medical device (examination gloves), not an algorithm or AI. Therefore, a standalone performance study in the context of "algorithm only" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of these gloves is based on:

• Laboratory Testing Results: Direct measurements of physical properties (e.g., water leak test) and chemical properties (e.g., protein content determination).
• Adherence to Established Standards: Conformance to recognized industry standards such as ASTM D 3578.

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI/machine learning device that requires a training set.

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

This question is not applicable, as there is no training set for this device.

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The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste or environment.

The Examination Glove is a medical glove which is disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between examiner and patient.

Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.

The document describes the acceptance criteria and performance data for "Glovetex Examination Gloves, Powdered Non-Sterile (Protein Content Labeling)".

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The document describes a study based on "Performance data of gloves to ASTM D 3578-99 and FDA 1000 ml Watertight Test." and "Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D 5712 — 95".

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

• The document does not specify the exact sample size used for the various tests. However, it refers to AQL (Acceptable Quality Level) values for Watertight (AQL 1.5) and Physical Properties (AQL 4.0), which are statistical sampling plans used in quality control. This implies that a sufficient sample size was tested to determine compliance with these AQLs.
• Data Provenance: The manufacturing company is listed as PT. WRP Buana Multicorpora in Medan-Labuhan Km 17, INDONESIA. The raw data would originate from their in-house testing facilities in Indonesia. The testing itself is retrospective, as it's a summary of performance data collected after manufacturing for the purpose of regulatory submission.

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 information is not applicable as the document describes performance testing for medical gloves, which relies on standardized physical and chemical tests rather than expert interpretation of medical images or conditions. The "ground truth" here is the objective measurement against the specified ASTM standards and in-house criteria.

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

• This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving subjective interpretation (e.g., medical image reading) where multiple experts might disagree. For the physical and chemical testing of gloves, objective measurements are taken against predefined criteria, and thus, no expert adjudication is required.

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:

• This information is not applicable. The device described is an examination glove, which is a physical product, not an AI-assisted diagnostic tool or an imaging device. Therefore, an MRMC study is not relevant.

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

• This information is not applicable. The device is an examination glove, not an algorithm.

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

• The ground truth used for this study is based on objective measurements against established industry standards (ASTM D 3578-99, ASTM D 5712-95) and the manufacturer's in-house specifications. This includes physical properties (e.g., tensile strength, elongation, dimensions), chemical properties (e.g., protein content, powder content, moisture content), and performance characteristics (e.g., watertightness).

8. The sample size for the training set:

• This information is not applicable. There is no "training set" in the context of testing a physical medical device like an examination glove. The performance data presented are results from testing a manufactured product against predefined specifications.

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

• This information is not applicable as there is no training set for this type of device testing.

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