(16 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. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs.
Positive Touch Powder Free Examination Gloves With Protein and Chemotherapy Labeling Claim are formulated using latex and are coated with a Polymer coating. These gloves are offered non-sterile in sizes X-small, Small, Medium, Large and X-large.
This document is a 510(k) Summary of Safety and Effectiveness for "Positive Touch Powder-Free Latex Examination Gloves With Protein & Chemotherapy Labeling Claim." As such, it reports on a device, not an algorithm or AI. Therefore, most of the requested fields are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | (Not explicitly stated, but expected to be non-irritating) | Glove does not display irritation potential. |
| Guinea Pig Maximization | (Not explicitly stated, but expected to be non-sensitizing) | Glove does not display sensitization potential. |
| Ultimate Elongation & Tensile Strength | Meets or exceeds requirements per ASTM D3578-01 for rubber examination gloves. | Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-01. |
| Barrier Defects | Meets or exceeds requirements per 21 CFR §800.20 and ASTM D3578-01, AQL=2.5. | Glove meets or exceeds requirements per 21 CFR §800.20 and ASTM D3578-01, AQL=2.5. |
| Powder Level | Meets powder level requirements for "Powder Free" designation per ASTM D 3578-01. | Glove meets powder level requirements for "Powder Free" designation per ASTM D 3578-01. |
| Protein Labeling Claim | 50 microgram or less of total water extractable protein per gram of glove. | Glove meets requirements for protein claim of 50 microgram or less of total water extractable protein per gram of glove using the ASTM Lowry test method (ASTM 5712-95). |
| Chemotherapy Drug Resistance | (Implied: tested for use with chemotherapy drugs according to ASTM F 739-99a) | This glove has been tested for use with chemotherapy drugs. (Further details would be in the ASTM F 739-99a report, which is not provided here). |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each of the tests (e.g., how many gloves were tested for barrier defects, how many animals for irritation/sensitization). The data provenance is internal to the manufacturer, Allegiance Healthcare Corporation, based in McGaw Park, Illinois, USA. The study is prospective in nature, as it is a pre-market notification for a medical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (gloves), not an AI/algorithm-based diagnostic or prognostic tool that requires expert interpretation for establishing ground truth. The tests are laboratory and physical performance tests against established standards.
4. Adjudication method for the test set
Not applicable. The tests performed are objective laboratory and physical measurements, not subjective evaluations requiring 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 a medical device (gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (gloves), not an algorithm.
7. The type of ground truth used
The ground truth for the device's performance is based on established industry standards and regulatory requirements, specifically:
- ASTM D3578-01 (Standard Specification for Rubber Examination Gloves) for physical characteristics (elongation, tensile strength, barrier defects, powder level).
- 21 CFR §800.20 (Barriers) for barrier defects.
- ASTM 5712-95 (Standard Test Method for Protein in Natural Rubber Latex Devices) for protein content.
- ASTM F 739-99a (Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact) for chemotherapy drug resistance.
- Standard toxicological testing methods (Primary Skin Irritation, Guinea Pig Maximization) for biocompatibility.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI/Machine Learning model that requires a training set. The "training" here refers to the development and manufacturing processes of the glove to meet specified standards.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's manufacturing and design would be the specifications and performance requirements derived from the standards listed above.
§ 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.