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Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powder free vinyl patient examination gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves, Colored (Yellow):

Acceptance Criteria and Device Performance Study

The information provided describes the non-clinical testing performed to establish substantial equivalence for the Powder Free Vinyl Patient Examination Gloves, Colored (Yellow).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves tested for pinholes, physical properties, or for biocompatibility studies).

• Test Set Sample Size: Not explicitly stated. The standards (ASTM D5250-06, 21 CFR 800.20, D6124-06, ISO 10993-10) define statistical sampling plans, but the specific number of units tested in this submission is not provided in the summary.
• Data Provenance: The studies are non-clinical, likely performed by the manufacturer or a contract research organization (CRO) in China, given the submitter's address. The data is retrospective in the sense that the testing was performed, and the results are being submitted for regulatory review.

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

This type of information is generally not applicable to the non-clinical testing of patient examination gloves. The "ground truth" is established by adherence to standardized testing protocols and measurement methodologies defined by the cited ASTM and CFR standards, not by expert consensus on subjective findings.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly when interpreting subjective outputs like medical images. For the non-clinical tests described for these gloves, the results are objective measurements (e.g., pass/fail for pinholes, numerical values for powder residual, observed biological reactions) and do not involve an adjudication process. The determination of "meets" or "passes" is based on comparing the measured outcome to the predefined threshold in the standard.

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

No, an MRMC comparative effectiveness study was not done. These studies are relevant for devices involving interpretation by multiple human readers (e.g., radiologists, pathologists) and assessing the impact of a device (like AI) on their performance. This device is a disposable medical glove, and its performance is evaluated through standardized physical and biological testing, not by human reader interpretation.

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

This question is not applicable to this device. "Standalone performance" refers to the performance of an algorithm or AI system without human intervention. This device is a physical medical product (a glove), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by the objective performance criteria specified in the referenced industry standards and regulations:

• Physical Properties: Defined by ASTM standard D 5250-06 (e.g., minimum tensile strength, elongation, dimensions).
• Freedom from Pinholes: Defined by 21 CFR 800.20 (Water Leak Test) with specific Acceptable Quality Limits (AQLs).
• Powder Residual: Defined by ASTM standard D 5250-06 and D6124-06 (maximum powder weight per glove).
• Biocompatibility: Defined by ISO 10993-10 (tests for primary skin irritation and dermal sensitization) with specific criteria for "passes" (e.g., minimal or no observed reaction).

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train machine learning models. This product is a physical medical device and does not involve machine learning or AI algorithms requiring 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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