(29 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 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, Powder-free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
Here's a breakdown of the acceptance criteria and study information for the SHANGHAI CHINASTAR CORP. Powder-free Vinyl Patient Examination Gloves, based on the provided text:
Important Note: This document describes a medical device, but it is not an AI/ML device. Therefore, many of the requested fields related to AI performance, ground truth, expert consensus, and training/test sets are Not Applicable (N/A) for this type of product. The acceptance criteria focus on physical properties, biocompatibility, and regulatory compliance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (based on ASTM D-5250-92) | All testing meets requirements for Physical and Dimensions Testing |
| Inspection Level S-2, AQL 4.0 | Meets requirements |
| FDA 1000 ml Water Fill Test | Meets requirements |
| Inspection Level S-4, AQL 2.5 | Meets requirements |
| Primary Skin Irritation Testing | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) Testing | No sensitization reactions |
| Powder-free claim (USP Iodine Test for Starch) | Adheres to all USP Iodine Test methodology; meets "powder-free" claim |
| Powder residue by weight | Adheres to all USP Iodine Test methodology |
| Particulate testing | Contracting with a laboratory for added assurance |
| Final release testing (Light transmission test using spectrophotometer) | Conducted |
| Pinhole requirements | Meets FDA requirements |
| Biocompatibility requirements | Meets requirements |
| Labeling claims | Meets requirements |
| Conformity to ASTM D-5250-92 standards | Conforms fully |
| Conformity to applicable 21 CFR references | Conforms fully |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- For Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The exact number of units is not specified, but this AQL (Acceptable Quality Level) implies a sampling plan.
- For FDA 1000 ml Water Fill Test: Inspection Level S-4, AQL 2.5. The exact number of units is not specified, but this AQL implies a sampling plan.
- For Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but clinical testing was conducted.
- For USP Iodine Test: Not explicitly stated, but conducted on "finished inspection."
- Data Provenance: Not explicitly stated, but the manufacturing company is based in Shanghai, China, suggesting the testing was performed there or by associated labs. The testing is retrospective in the sense that it's performed on manufactured products to ensure quality and compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is a non-AI device. Ground truth for a glove focuses on objective measurements and established standards (e.g., tensile strength, dimensional accuracy, water leak tests, chemical composition). Expert consensus, in the sense of clinical interpretation, is not relevant here.
4. Adjudication method for the test set
- N/A. As this is a non-AI device, there's no "adjudication" in the context of expert review for ambiguous cases. The testing involves standardized procedures and objective measurements that either meet or do not meet predefined criteria.
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
- N/A. This is a non-AI device. MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a non-AI device.
7. The type of ground truth used
- The "ground truth" for this device constitutes objective, measurable standards and specifications defined by regulatory bodies (FDA) and industry standards (ASTM D-5250-92). This includes:
- Objective Measurements: Physical dimensions, tensile strength, elongation, force at break (implied by ASTM D-5250-92).
- Pass/Fail Tests: Water leak test (FDA 1000 ml Water Fill Test), USP Iodine Test for starch, primary skin irritation, skin sensitization.
- Chemical Analysis: Ensuring "powder-free" status and absence of sensitizing agents.
8. The sample size for the training set
- N/A. This is a non-AI device; there is no "training set."
9. How the ground truth for the training set was established
- N/A. This is a non-AI device; there is no "training set."
§ 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.