Search Results

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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided text regarding acceptance criteria and the study:

Acceptance Criteria and Device Performance Study

This submission concerns the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)" (K100734).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many rabbits/guinea pigs were used for biocompatibility). It generally states that the device "meets" the requirements of the specified standards.

The provenance of the data is not explicitly mentioned with respect to country of origin or whether it was retrospective or prospective. However, given that these are standard tests for medical devices, they would typically be conducted by accredited laboratories following established protocols.

3. Number of Experts and Qualifications for Ground Truth Establishment

This type of device (patient examination gloves) does not typically involve human expert interpretation for establishing ground truth in performance testing. The "ground truth" is established by direct measurement and compliance with predefined numerical or qualitative criteria specified in the ASTM standards and FDA regulations.

4. Adjudication Method for Test Set

Not applicable. The "ground truth" for the performance of gloves is determined by objective physical and chemical tests against established standards, not by human interpretation requiring adjudication.

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

Not applicable. This device is a passive medical device (gloves) and does not involve human readers or AI assistance in its function or evaluation. Therefore, an MRMC study or an effect size of AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical product (gloves), not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance is derived from:

• Established Industry Standards: ASTM standard D 5250-06 and ASTM D6124-06 for dimension, physical properties, and powder residue.
• FDA Regulations: 21 CFR 800.20 for freedom from pinholes (AQL - Acceptable Quality Limit).
• Biocompatibility Standards: ISO10993-10, which guides the primary skin irritation and dermal sensitization tests. The results are qualitative ("Passes," "Not a Primary Skin Irritation," "Not a Dermal Sensitization").

8. Sample Size for Training Set

Not applicable. This device is a physical product, and its evaluation does not involve machine learning algorithms requiring a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device