(59 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 and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
The provided text describes the regulatory clearance for "Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue." It outlines the device's characteristics, intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ASTM D 6319-00a (2005)e1 | "All testing meets requirements for physical and dimensions testing conducted on gloves." |
| Pinhole FDA requirements (Water Fill Test) | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements." |
| Biocompatibility (Primary Skin Irritation) | "Primary Skin Irritation... testing was conducted with results showing no primary skin irritant reactions." |
| Biocompatibility (Skin Sensitization) | "...Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no...sensitization reactions." |
| "Powder-free" claim (Residual Powder Test) | "A Residual Powder Test that based on ASTM D 6124-06 for powder at finished inspection is conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per glove)." |
| Labeling | "There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Pinhole (Water Fill Test): Inspection level I, AQL 2.5. The specific number of samples is not explicitly stated but is implied by the AQL (Acceptable Quality Limit) and inspection level. These are statistical sampling plans.
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. Similar to the pinhole test, the exact number isn't given but is derived from the AQL and inspection level.
- Primary Skin Irritation and Skin Sensitization: The sample size for these biological tests is not specified in the document.
- Residual Powder Test: Not explicitly stated but implies testing of "finished inspection" gloves.
- Data Provenance: The manufacturing company, Better Care Plastic Technology Co., Ltd., is located in Hebei Province, China. It is highly likely the testing was conducted in China. The data is presented as results from tests performed on the device during its production or evaluation, implying a prospective testing approach for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this device. This document describes the testing of a physical medical device (examination gloves) for performance characteristics (e.g., strength, impermeability, biocompatibility) against established engineering standards (ASTM) and regulatory requirements (FDA). It does not involve human interpretation of data where "ground truth" would be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the evaluation involves objective physical and chemical measurements against predefined standards, not subjective expert assessment 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
This is not applicable. The device is an examination glove, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is an examination glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is defined by established regulatory and industry standards:
- ASTM D 6319-00a (2005)e1 for physical and dimensional properties.
- FDA 1000 ml. Water Fill Test for pinhole integrity.
- ASTM D 6124-06 for residual powder.
- Biocompatibility testing against generally accepted methods for primary skin irritation and sensitization.
8. The sample size for the training set
This is not applicable. There is no "training set" as this device is a physical product, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as 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.