(87 days)
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, Patient Examination Glove, 80LYY, and meets all requirements of ASTM Standard D 3578-01aE2.
The provided text is a 510(k) summary for a medical device: "Powder Free Natural Rubber Latex Patient Examination Gloves with a Protein Labeling Claim (50 micrograms or less) and Made from Allotex® an Enzyme Treated Natural Rubber Latex." This document describes the device's characteristics and its substantial equivalence to a predicate device, rather than a study evaluating the performance of an AI-powered device. Therefore, much of the requested information, such as sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, and training set details, is not applicable to this type of regulatory submission.
However, I can extract the relevant "acceptance criteria" (which in this context refers to performance standards for the gloves) and the "reported device performance" based on the non-clinical tests performed.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: ASTM D 3578-01aE2, Inspection Level S-2, AQL 4.0 | Meets requirements for Physical and Dimensions Testing |
| Water Fill Test: "Maximum Fill" test, AQL 2.5, Inspection Level G-1 | Meets requirements |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| Residual Powder Test: ASTM D6124-01 for Starch (no more than 2 mg powder per glove) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
| Protein Labeling Claim: 50 micrograms or less (implied standard from predicate) | Meets protein labeling claim (50 micrograms or less) |
| Pinhole Requirement: FDA requirements (implied) | Meets pinhole FDA requirements |
| Biocompatibility Requirements (implied) | Meets biocompatibility requirements |
| Labeling Claims (implied) | Meets labeling claims |
| Overall Standard Conformance: ASTM D 3578-01aE2 | Conforms fully to ASTM D 3578-01aE2 standard |
| Overall Regulatory Conformance: Applicable 21 CFR references | Conforms fully to applicable 21 CFR references |
2. Sample size used for the test set and the data provenance:
- Sample Size for Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The exact numerical sample size is not explicitly stated, but these AQL (Acceptable Quality Limit) levels refer to standard sampling plans outlined in ISO 2859 (or equivalent standards) which would dictate specific sample sizes based on lot size.
- Sample Size for Water Fill Test: AQL 2.5, Inspection Level G-1. Similar to above, the exact numerical sample size is not explicitly stated but is determined by the AQL and inspection levels.
- Sample Size for Primary Skin Irritation and Skin Sensitization: Not specified.
- Sample Size for Residual Powder Test: Not specified.
- Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Tillotson Rubber Products Co., Ltd., presumably in China (its country of origin). The data is retrospective in the sense that the tests were performed on finished products before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as this document pertains to the physical and chemical testing of medical gloves, not the evaluation of an AI-powered diagnostic device requiring expert interpretation of outputs. The "ground truth" here is objective measurements and industrial standards.
4. Adjudication method for the test set:
Not applicable. The tests involve objective measurements against established ASTM standards and FDA requirements, not subjective expert 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-powered device, and no human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI-powered device.
7. The type of ground truth used:
The ground truth used for these tests includes:
- Objective Measurements against Standards: For physical properties (tensile strength, elongation, dimensions), pinholes, residual powder, and protein content.
- Biocompatibility Testing Standards: For primary skin irritation and sensitization.
- Regulatory Requirements: FDA's pinhole requirements and general biocompatibility expectations.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device; there is no training set mentioned.
9. How the ground truth for the training set was established:
Not applicable. 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.