(78 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.
A patient examination glove is disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
Here's a breakdown of the acceptance criteria and study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ASTM Standard D5250-92 for Physical and Dimensions Testing | Meets all requirements of ASTM Standard D5250-92 |
| FDA 1000 ml. Water Fill Test (AQL 2.5, Inspection Level S-4) | Meets requirements |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| Pinhole FDA requirements | Meets pinhole FDA requirements |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., Physical and Dimensions, Water Fill, Biocompatibility). It mentions:
- Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0
- FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level S-4
The data provenance is implied to be from Shijiazhuang Hongxiang Plastics Products Co., Ltd. in P.R. China, based on their testing of their own product. The studies appear to be retrospective in the sense that they were conducted on already manufactured products to ensure compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is Not Applicable to this submission. The device is a patient examination glove, and the "ground truth" for its performance is established through standardized physical, chemical, and biological tests, not through expert interpretation of data like in medical imaging.
4. Adjudication Method for the Test Set
This information is Not Applicable as the ground truth is established through objective, standardized tests, not through subjective human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the performance of human readers with and without AI assistance, typically in diagnostic tasks. This device is a medical glove, which doesn't involve diagnostic reading.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is Not Applicable. The device is a physical product (a glove), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.
7. The Type of Ground Truth Used
The ground truth used for assessing this device's performance is based on standardized test specifications (ASTM D5250-92 and FDA Water Fill Test requirements) and biological test results (primary skin irritation and skin sensitization).
8. The Sample Size for the Training Set
This information is Not Applicable. There is no "training set" in the context of this device. The manufacturer produces a product and tests it against established standards. This is not an AI/machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established
This information is Not Applicable for the reasons stated in point 8.
§ 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.