(62 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
This is not a medical device that utilizes AI/ML. The provided text is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," which is a Class I medical device. Therefore, information related to AI/ML specific criteria such as multi-reader multi-case studies, effect size of human readers with AI assistance, standalone algorithm performance, or training set details is not applicable and cannot be extracted from this document.
However, I can provide the acceptance criteria and the studies that prove the device meets these criteria based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Reference Section |
|---|---|---|---|
| Physical and Dimensions | Conformance to ASTM D-5250-06e1 | "All testing meets requirements for physical and dimensions testing conducted on gloves." | Section 7 |
| Freedom from Pinhole Defects | FDA 1000 ml. Water Fill Test requirements (AQL 2.5, inspection level I) | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements." | Section 7 |
| Biocompatibility - Primary Skin Irritation | No primary skin irritant reactions | "Primary Skin Irritation...testing was conducted with results showing no primary skin irritant...reactions." | Section 7 |
| Biocompatibility - Skin Sensitization | No sensitization reactions (allergic contact dermatitis) | "...Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no...sensitization reactions." | Section 7 |
| Residual Powder | No more than 2 mg powder per glove (based on ASTM D-6124-06) | "...our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per glove)." | Section 7 |
| General Equivalence | As safe, as effective, and performs as well as or better than the predicate device (Better Care Plastic Products Co., Ltd Powder Free Vinyl Patient Examination Glove) | "Grand Work Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves conform fully to ASTM D-5250-06e1 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the 'substantial equivalence' products cited. The device herein mentioned is as safe, as effective, and performs as well as or better than the predicate device." | Section 10 |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0." (Specific numerical sample size not provided, but AQL and inspection level are specified which determine the sample size. The data provenance is internal testing by the manufacturer.)
- FDA 1000 ml. Water Fill Test: "samplings of AQL 2.5, inspection level I." (Specific numerical sample size not provided, but AQL and inspection level are specified. The data provenance is internal testing by the manufacturer.)
- Primary Skin Irritation and Skin Sensitization: The document does not specify the sample size for human or animal subjects used in these tests. The testing was conducted, implying it's a prospective study for the purpose of this submission.
- Residual Powder Test: The document does not specify the sample size. The data provenance is internal testing by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical product (examination gloves), and the "ground truth" is established through standardized physical, chemical, and biological testing rather than expert-based interpretations.
4. Adjudication method for the test set
Not applicable. The testing methods for physical properties, pinholes, and biocompatibility are objective measurements against established standards, not subjective interpretations requiring 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 is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
The "ground truth" for the device's performance is based on objective measurements against established national and international standards for medical gloves:
- ASTM D-5250-06e1 (Standard Specification for Vinyl Patient Examination Gloves) for physical and dimensional properties.
- FDA 1000 ml. Water Fill Test for barrier integrity (pinholes).
- Primary Skin Irritation and Skin Sensitization testing for biocompatibility.
- ASTM D-6124-06 for Residual Powder.
8. The sample size for the training set
Not applicable. There is no AI/ML algorithm or training set for this type of device. The "training" for manufacturing would involve adherence to quality control processes and standards.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.
§ 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.