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Powder Free Latex Examination Gloves, 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, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a 22 and FDA 1000 ml Water Leak Test.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PT. Mandiri Inti Buana examination gloves:

Overview:

This submission describes a Class I medical device (Powder Free Latex Examination Gloves, Non-Sterile) and seeks a 510(k) clearance based on substantial equivalence to legally marketed predicate devices. The "study" here refers to non-clinical performance testing conducted to demonstrate compliance with established standards.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on the "Study" and Performance Data:

The document describes non-clinical performance testing that demonstrates the device meets the specified ASTM standards and FDA requirements. This is not a "study" in the traditional sense of a clinical trial or a comparative effectiveness study involving human subjects or experts, but rather a series of laboratory tests.

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

• Sample Size: The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many rabbits for biocompatibility). It simply states that the device "Meets" the standards or provides a quantitative result (e.g., "< 2 mg/glove"). The sample sizes would be dictated by the specific ASTM and FDA test methods referenced (e.g., D 3578-01ae2, D 6124-01, D 5712-99, and FDA 21 CFR 800.20).
• Data Provenance: The document does not explicitly state the country of origin for the test data itself. The manufacturer is located in Indonesia. The testing would have been conducted in a laboratory, but the location of that lab is not specified. The data is retrospective in the sense that the tests were performed and analyzed before the 510(k) submission.

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

• Experts: Not applicable in the context of this device. The "ground truth" for these tests are the objective measurements and pass/fail criteria defined by the ASTM standards and FDA regulations themselves.
• Qualifications: The individuals performing the tests would be qualified lab technicians, but their specific number and qualifications are not mentioned as they are performing established, standardized tests, not making subjective expert judgments like in image analysis or diagnostic studies.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests are objective measurements against established standards. There is no subjective interpretation requiring an adjudication process. Results are either "Meets" or they don't, or they fall within a specified quantitative range.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret cases and their performance (with and without AI assistance) is compared. These gloves are a Class I barrier device, not a diagnostic tool requiring human interpretation.

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

• Standalone Performance: Not applicable. This device does not involve an algorithm or AI. Its performance is assessed through physical, chemical, and biological laboratory tests, not automated analysis.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device is based on established and objective physical, chemical, and biological standards. Specifically:
  • ASTM standards (e.g., D 3578-01ae2 for dimensions, physical properties, freedom from pinholes; D 6124-01 for powder residue; D 5712-99 for water soluble protein content).
  • FDA regulations (e.g., 21 CFR 800.20 for the 1000 ml Water Leak Test for pinholes).
  • Biocompatibility test methods (Primary Skin Irritation in Rabbits, Dermal Sensitization), which have established protocols and endpoints for determining "Pass" or "Fail."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no training set.

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