(116 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
The provided text describes a 510(k) summary for Rich Mountain Medical Products Inc.'s Disposable Powder Free Vinyl Synthetic Exam Gloves With Aloe Vera, Green Color. This document is a premarket notification for a medical device and therefore focuses on demonstrating "substantial equivalence" to a predicate device rather than providing detailed acceptance criteria and a comprehensive study that proves the device meets those criteria in the way a more advanced AI/ML device would.
However, I can extract the relevant information from the document to construct the closest possible answer based on the provided text, interpreting the "device performance" in terms of compliance with relevant standards and tests for gloves.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|
| ASTM D5250-06 (Physical and Dimensions Testing) | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0. Conforms fully. |
| FDA 1000 ml Watertight Test based on ASTM D-5151-06 (Pinhole integrity) | Conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements. Meets pinhole FDA requirements. |
| Biocompatibility - Primary Skin Irritation | Results showing no primary skin irritant reactions. |
| Biocompatibility - Skin Sensitization (allergic contact dermatitis) | Results showing no sensitization reactions. |
| ASTM D6124-06 (Residual Powder Test for "powder-free" claim) | Conducted at finished inspection to ensure gloves contain no more than 2 mg powder per glove. |
2. Sample size used for the test set and the data provenance
- ASTM D5250-06 (Physical and Dimensions Testing): Inspection level S-2, AQL 4.0. (Specific sample size not provided, but implies standard sampling per ASTM).
- FDA 1000 ml Watertight Test based on ASTM D-5151-06 (Pinhole integrity): AQL 2.5, Inspection level I. (Specific sample size not provided, but implies standard sampling per ASTM).
- Biocompatibility (Primary Skin Irritation and Skin Sensitization): Not specified.
- Data Provenance: Not explicitly stated, but assumed to be from tests conducted by the manufacturer, Rich Mountain Medical Products Inc. No mention of country of origin for the testing data itself, but the manufacturer is in China. Retrospective/Prospective is not applicable in this context as these are manufacturing quality control tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a medical glove, "ground truth" is established by adherence to predefined engineering and biological standards (e.g., ASTM standards for physical properties, ISO standards for biocompatibility). The "truth" is whether the glove meets the defined pass/fail criteria of these standardized tests, not an expert's interpretive assessment.
4. Adjudication method for the test set
Not applicable. The tests involve objective measurements against established criteria, not subjective expert judgment that would require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a disposable medical glove, not an AI/ML-driven diagnostic or interpretative system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI. It is a physical device.
7. The type of ground truth used
The ground truth used is based on:
- Engineering standards (e.g., ASTM for physical dimensions, tensile strength, elongation).
- Performance standards (e.g., ASTM for watertightness/pinhole integrity).
- Biocompatibility standards (e.g., for skin irritation and sensitization).
- Chemical residue standards (e.g., for powder content).
8. The sample size for the training set
Not applicable. This device does not involve a training set in the context of AI/ML. Manufacturing processes are optimized over time, but this doesn't constitute a "training set" in the sense of AI.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" in the AI/ML sense for this device. The ground truth for the device's performance is established by the specified ASTM and FDA testing standards.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.