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Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05

This document pertains to the 510(k) premarket notification for "Nitrile Powder Free Patient Examination Gloves, Coloured (Blue)" submitted by Tangshan Xiangrui Plastic Products Co., Ltd. The product is a disposable, non-sterile glove intended for medical purposes to prevent cross-contamination.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is assessed against established industry standards and FDA regulations for patient examination gloves.

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

The document does not explicitly state the specific sample sizes for each test mentioned (Dimension, Physical Properties, Freedom from Pinhole, Powder Residual, Biocompatibility). However, it implies that the testing was performed on samples of the "Nitrile Powder Free Patient Examination Gloves, Coloured (Blue)" manufactured by the applicant.

The data provenance is from non-clinical testing performed on the applicant's device. The country of origin of the data is not explicitly stated, but given the applicant's location (Tangshan City, Hebei Province, China), it can be inferred that the testing was likely conducted in China or by labs contracted by the Chinese manufacturer. The testing is prospective in the sense that it was conducted on the newly manufactured device to demonstrate its conformity to standards.

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 evaluations for this device (patient examination gloves) are based on objective, standardized physical and chemical tests, not on expert interpretation of complex data or images. The "ground truth" is defined by the objective pass/fail criteria of the ASTM standards and CFR regulations.

4. Adjudication Method for the Test Set

This information is not applicable. The tests performed are objective and quantitative (e.g., measuring dimensions, tensile strength, liquid leakage, chemical residue). They do not involve subjective interpretation that would require an adjudication method like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and AI's assistance to these readers is evaluated. Patient examination gloves do not involve such a scenario.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This information is not applicable. Patient examination gloves are a physical product, not an algorithm or software. Therefore, there is no "standalone algorithm" performance to report.

7. Type of Ground Truth Used

The ground truth used for evaluating the device is based on objective, quantitative standards and regulatory requirements. Specifically:

• ASTM standard D 6139-05 for Dimension and Physical Properties.
• 21 CFR 800.20 for Freedom from pinholes.
• ASTM standard D 5250-06 and D6124-06 for Powder Residual.
• ISO10993-10 (implied for biocompatibility based on the discussion in b(1)) and general biocompatibility testing protocols for Primary Skin Irritation (in rabbits) and Dermal sensitization (in guinea pigs).

8. Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as no training set was used.

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