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Proflex Powderfree Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

PROFLEX* Powder Free Nitrile Examination Gloves meet the current draft ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 3578 – 95, Standard Specification for Rubber Examination Gloves, EXCEPT for tensile strength and ultimate elongation requirement. They are blue or natural white in colour and are powder free.

Here's a breakdown of the acceptance criteria and the study information for the PROFLEX* POWDER FREE NITRILE EXAMINATION GLOVES, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (examination gloves). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing against established standards. It does not typically involve clinical studies with human participants in the way that, for example, an AI diagnostic device would. Therefore, many of the requested fields related to human readers, experts, ground truth for AI, etc., are not applicable to this type of device and submission.

1. Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are based on compliance with established industry standards for examination gloves.

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

• Sample Size: Not explicitly stated in the provided text. Testing was performed "per ASTM D 3578-95 (also per current draft ASTM Standard Specification for Nitrile Examination Gloves for Medical Application) and 21 CFR 800.20." These standards typically define sampling plans for testing.
• Data Provenance: Not specified. The testing was conducted by the manufacturer, Latex Partners Bhd. (Malaysia). The tests are non-clinical (laboratory and animal studies).

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

• Not Applicable. This is a non-clinical device performance study. Ground truth is established by objective measurements against specified standard criteria (e.g., physical properties, chemical tests).

4. Adjudication Method for the Test Set

• Not Applicable. This is a non-clinical device performance study. Test results are compared directly to the specified criteria in the standards.

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. This type of study is entirely irrelevant for an examination glove. This is a non-clinical device.

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

• No. This is a non-clinical device, not an AI algorithm.

7. The Type of Ground Truth Used

• Standard Specifications and Objective Measurements: For the physical properties (e.g., dimensions, freedom from holes), chemical properties (e.g., starch presence), and biological safety (skin irritation, sensitization), the "ground truth" is established by the specified requirements in the ASTM standards and the results of laboratory tests (e.g., animal studies for biocompatibility).

8. The Sample Size for the Training Set

• Not Applicable. This is a non-clinical device, not an AI algorithm requiring a training set.

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

• Not Applicable. This is a non-clinical device, not an AI algorithm.

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