(30 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
The Vinyl Plastic Co-Polymer Powder-Free Examination Gloves (Blue Color) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00a1 and ASTM D-5250.
The provided document describes the safety and effectiveness information for the "Grand Work Plastic Products Co., Ltd. Vinyl Nitrile Co-Polymer Powder Free Exam Gloves (Blue Color)".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing | Meets requirements of ASTM D-6319-00a1 and ASTM D-5250 (Inspection level S-2, AQL 4.0) | Meets requirements of ASTM D-6319-00a1 and ASTM D-5250 (All testing meets requirements) |
| Pinhole (Water Fill Test) | Meets requirements of FDA 1000 ml. Water Fill Test based on ASTM D-5151-99 (AQL 2.5, inspection level G-1) | Meets requirements of FDA 1000 ml. Water Fill Test based on ASTM D-5151-99 (Met requirements) |
| Primary Skin Irritation | No primary skin irritant reactions | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions | No sensitization reactions |
| Residual Powder | No more than 2 mg powder per glove (based on ASTM D-6124-01 for Starch) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact sample size is not explicitly stated but is determined by the AQL and inspection level standards.
- Pinhole (Water Fill Test): Inspection level G-1, AQL 2.5. The exact sample size is not explicitly stated but is determined by the AQL and inspection level standards.
- Primary Skin Irritation and Skin Sensitization: Sample size not specified.
- Residual Powder Test: Sample size not specified.
- Data Provenance: Not explicitly stated, however, the submitter is based in China, suggesting the testing likely occurred in China or at an approved testing facility. The data is reported as part of a premarket notification (510(k)), representing retrospective data collected for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The tests performed are objective, laboratory-based tests (e.g., physical measurements, chemical analysis, biocompatibility assays) that do not require human expert interpretation to establish ground truth in the way medical imaging or clinical diagnoses would. The "ground truth" is established by the results of the standardized tests themselves against predefined criteria.
4. Adjudication method for the test set
- Not applicable. As noted above, the tests are objective and do not involve human interpretation that would necessitate adjudication. The results are compared directly to the specified ASTM standards and thresholds.
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 is a medical device (examination glove) and not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (examination glove) and not an algorithm or AI system.
7. The type of ground truth used
- Objective measurements against established standards: The ground truth for this device is based on objective laboratory measurements and tests conforming to recognized industry standards (ASTM D-6319-00a1, ASTM D-5250, ASTM D-5151-99, ASTM D-6124-01) and regulatory requirements (FDA 1000 ml. Water Fill Test, biocompatibility guidelines for primary skin irritation and sensitization). The "ground truth" is whether the physical, chemical, and biological properties of the gloves meet these predefined quantitative criteria.
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
§ 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.