(422 days)
Palm Pro X - Powder Free Latex Examination Gloves (6PF2G30) 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.
Patient Examination Gloves (21 CFR 880.6250)
Product Class: I
Product Code: 80 LYY (Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578-05.). The gloves are made of natural latex rubber and are worn on the examiner's hand to prevent contamination between patient and examiner.
The provided text describes the acceptance criteria and performance of the Palm Pro X - Powder Free Latex Examination Gloves. However, it does not describe a study in the context of an AI/ML device, but rather the general performance testing for a medical glove. Therefore, most of the requested fields regarding AI/ML study specifics (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This table combines the "Dimension Characteristics" and "Performance Characteristics" from the provided document, comparing the Palm Pro X gloves to ASTM standards and predicate devices.
| Characteristic | Acceptance Criteria (ASTM D3578-05) | Palm Pro X Performance |
|---|---|---|
| Dimension Characteristics | ||
| Thickness (Finger) | 0.08 min | 0.37 ± 0.03 mm |
| Thickness (Palm) | 0.08 min | 0.30 min |
| Palm Width (XS) | 70 ± 10 mm | 77 mm |
| Palm Width (S) | 80 ± 10 mm | 85 mm |
| Palm Width (M) | 95 ± 10 mm | 95 mm |
| Palm Width (L) | 111 ± 10 mm | 110 mm |
| Palm Width (XL) | N/A | 118 mm |
| Length | 220/230 min | 300 min |
| Performance Characteristics | ||
| Tensile Strength (unaged) | 18 min MPa | 21 min MPa |
| Tensile Strength (aged) | 14 min MPa | 16 min MPa |
| Elongation at break (unaged) | 650 min % | 750 min % |
| Elongation at break (aged) | 500 min % | 600 min % |
| Extractable Protein Content | 200 µg/dm² | 50 µg/g or less |
Note: "min" refers to "minimum" in the original document.
Study Information (Applicable to General Device Testing)
2. Sample size used for the test set and the data provenance:
- The document does not specify the sample sizes used for testing each characteristic.
- Data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. The testing appears to be conducted on manufactured gloves to ensure compliance with standards.
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 physical product (gloves) and not an AI/ML device. Ground truth for these characteristics is established through standardized physical and chemical testing methods, not expert human assessment.
4. Adjudication method for the test set:
- Not Applicable: As stated above, this is for a physical product, not an AI/ML output requiring adjudication. Performance is measured against objective standards.
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 physical product (gloves), not an AI/ML device, and therefore MRMC studies are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a physical product; there is no algorithm or standalone performance in the context of AI.
7. The type of ground truth used:
- The "ground truth" for the performance characteristics of the gloves is established by ASTM D3578-05 standard specifications for physical dimensions, tensile strength, elongation at break, and extractable protein content. These are objective, measurable standards.
8. The sample size for the training set:
- Not Applicable: There is no "training set" in the context of this physical product. The manufacturing process is designed to meet desired specifications.
9. How the ground truth for the training set was established:
- Not Applicable: As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for glove manufacturing is adherence to established industry standards like ASTM D3578-05.
§ 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.