(274 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 a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
The provided text describes a 510(k) summary for "Shandong Zhiyuan Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves -- Powder Free, Yellow Color". This document is for a medical device (examination gloves) and focuses on demonstrating substantial equivalence to predicate devices, rather than an AI-powered diagnostic device from the perspective of an acceptance criteria table.
Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable to this type of device submission. The submission is primarily based on meeting established physical and biological standards for examination gloves.
Here's an analysis of the provided information within the context of the prompt, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Physical Dimensions & Performance | Conformance to ASTM D5250-06 standard | Fully conforms to ASTM D5250-06 standard. |
| Inspection Level (Physical) | S-2 | |
| AQL (Physical) | 2.5 | |
| Barrier Integrity | FDA 1000 ml. Water Fill Test | Meets requirements |
| AQL (Water Fill Test) | 2.5 | |
| Inspection Level (Water Fill Test) | I | |
| Biocompatibility | Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions | |
| Powder-Free Claim | Powder content | Contains no more than 2 mg powder per glove |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single "test set" sample size. The document refers to "samplings" for the FDA 1000 ml Water Fill Test and for physical/dimensions testing, indicating that batches of gloves were tested according to AQL (Acceptable Quality Level) standards. AQL 2.5 usually implies a sampling plan where a certain number of gloves are inspected from each lot based on lot size, and if the number of defects exceeds a pre-defined limit, the lot is rejected.
- Data Provenance: The testing was conducted by Shandong Zhiyuan Medical Products Co., Ltd. (China). The data is retrospective in the sense that it was collected from manufactured gloves for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable: This product is a physical medical device (gloves), not an AI-powered diagnostic tool requiring expert ground truth for image or data interpretation. The "ground truth" is based on objective physical, chemical, and biological test results as per established standards and protocols.
4. Adjudication Method
- Not Applicable: There is no "adjudication method" in the context of expert review for diagnostic output. The tests (e.g., water fill, skin irritation) have defined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable: This is not an AI-powered diagnostic device where human reader improvement with AI assistance would be relevant.
6. Standalone Performance
- Not Applicable: Standalone performance, in the context of an AI algorithm operating without human intervention, is not applicable to an examination glove. The performance evaluation here is about the device itself meeting physical and biological specifications.
7. Type of Ground Truth Used
- Objective Test Results and Standards Conformance: The "ground truth" for this device's performance is established by:
- ASTM Standard D5250-06: A consensus standard for vinyl patient examination gloves.
- FDA 1000 ml Water Fill Test: A standardized test for pinhole defects.
- Biocompatibility Testing Protocols: Standardized tests for primary skin irritation and sensitization.
- Gravimetric Analysis: To determine powder content.
8. Sample Size for the Training Set
- Not Applicable: There is no "training set" in the AI/machine learning sense for this device. The manufacturing process of gloves does not involve training an algorithm from data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set, this question is not applicable.
§ 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.