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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LZA, and meets all requirement of ASTM Standard D6319-05.

The provided text describes the regulatory clearance (510(k) submission) for "Shandong Junchi Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free, Blue Color", not a KIBIEST medical device. The document pertains to the device's substantial equivalence to a predicate device and its compliance with relevant ASTM standards and FDA regulations for patient examination gloves.

Therefore, the requested information about acceptance criteria and a study proving a medical device's performance (in the context of AI, imaging, or diagnostics, as often implied by such questions) is not directly applicable to this document. This document focuses on the physical and biocompatibility properties of a disposable medical glove.

However, I can extract the information relevant to the testing performed for these gloves, framed as an answer to the prompt's structure even if the context is different from a typical "device performance study" for a more complex medical device:

Acceptance Criteria and Study for Shandong Junchi Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free, Blue Color

This document details the non-clinical tests performed to demonstrate the substantial equivalence of the Shandong Junchi Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves to a predicate device. The primary focus is on compliance with established standards for physical properties, barrier integrity, and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The exact sample size for each specific test (e.g., number of gloves for physical testing, number of subjects for biocompatibility) is not explicitly stated in the provided text. However, it mentions "samplings of AQL 2.5, Inspection Level I" for the water fill test, indicating a statistically valid sampling plan. Physical and Dimensions Testing indicates "Inspection Level S-2, AOL 2.5."
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given that the manufacturer is in China, it's highly probable the testing was conducted there. The biocompatibility tests are prospective in nature.

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

This type of information is not applicable to the evaluation of medical gloves. The "ground truth" for these tests is defined by established scientific methods and pass/fail criteria of the ASTM standards and FDA regulations (e.g., a specific measurement value, presence/absence of irritation). Expert consensus in the context of interpretation (like radiology) is not relevant here.

4. Adjudication Method for the Test Set

This concept is not applicable to the evaluation of medical gloves. Test outcomes are typically objective measurements or observations (e.g., a glove failed the water leak test, a skin patch test showed no reaction).

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 diagnostic devices where human readers interpret medical images or data. This document pertains to the physical and biological properties of a glove.

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

No, a standalone "algorithm only" performance study was not done. This device is a physical medical product (a glove), not a software algorithm or AI-driven system.

7. The Type of Ground Truth Used

The "ground truth" for these tests is based on established scientific and engineering standards and biological testing results:

• ASTM D6319-10: Specifies physical and dimensional properties (e.g., tensile strength, elongation, dimensions).
• FDA 1000 mL Water Fill Test: Determines barrier integrity (pinhole detection).
• Biocompatibility Testing: Primary Skin Irritation and Skin Sensitization tests are standardized biological assays to assess potential adverse reactions in living tissue.
• Powder Content Measurement: Objective quantification of residual powder.

8. The Sample Size for the Training Set

This concept is not applicable. There is no "training set" in the context of physical and biocompatibility testing for a medical glove. The product is manufactured and then tested against predefined criteria.

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

This concept is not applicable for the reasons outlined in point 8.

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