(101 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
The Powder Free Nitrile Examination Gloves (Blue) meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) Pre-market Notification for Powder Free Nitrile Examination Gloves (Blue). This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on product safety and effectiveness standards rather than complex AI algorithm performance.
Therefore, the requested information pertaining to AI algorithm studies (sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable to this device.
The study described in this document is a non-clinical performance evaluation to demonstrate adherence to established medical device standards.
Here's the relevant information based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS & ACCEPTANCE CRITERIA | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D6319-10: | |
| Length: Size XS & S - min. 220mm; Size M & L - min. 230mm | ||
| Width - min. 95 ± 10mm (Note: Comparison table implies specific widths for each size) | Meets ASTM D6319-10 Standard requirements | |
| Minimal Value for Length: 240mm | ||
| Minimal Value for Width: 93mm (Note: This is a minimal value, implying other sizes met their specific width criteria. The comparison table shows the device claims to meet exact width ranges per size.) | ||
| Physical Properties | ASTM D6319-10: | |
| Tensile Strength: Before Aging: 14 MPa; After Aging: 14 MPa | ||
| Ultimate Elongation: Before Aging: min. 500%; After Aging: min. 400% | Meets ASTM D6319-10 Standard requirements | |
| Tensile Strength: Before Aging: Minimal Value: 16.20 MPa; After Accelerated Aging: Minimal Value: 16.16 MPa | ||
| Ultimate Elongation: Before Aging Minimal Value: 661%; After Aging Minimal Value: 630% | ||
| Thickness | ASTM D6319-10: | |
| Min. 0.05mm | Meets ASTM D6319-10 Standard requirements | |
| Palm – Minimal Value: 0.06mm | ||
| Finger – Minimal Value: 0.13mm | ||
| Biocompatibility (Irritation) | ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass (Under the conditions of the study, the test article is a non-irritant) |
| Biocompatibility (Sensitization) | ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass (Under the conditions of the study, the test article is a non-sensitizer) |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151-06 | |
| AQL 2.5 | Meets 21 CFR 800.20 and ASTM D5151-06 Standard requirements | |
| Passes AQL 2.5 | ||
| Powder Residual | ASTM D6124-06: | |
| ≤ 2 mg / glove | Meets ASTM D6124-06 Standard requirements | |
| Minimal Value: 0.68 mg |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for dimensions, tensile strength, pinholes, etc.).
- The data provenance is implied to be from tests conducted on the manufacturer's product, Nam Viet Glove Joint Stock Company in Vietnam. The description of tests being performed on "the test article" implies prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of medical device (examination gloves), "ground truth" is established by adherence to physical and chemical standards and test methods outlined by organizations like ASTM and ISO, not human expert consensus on interpretations. The results are objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As mentioned above, the tests involve objective measurements against predefined 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 device is a physical product (nitrile gloves), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is defined by the objective specifications and quantifiable limits set by international standards (ASTM D6319-10, ISO 10993-10, ASTM D5151-06, ASTM D6124-06) and FDA regulations (21 CFR 800.20). Performance is measured directly against these specified values.
8. The sample size for the training set:
- Not Applicable. This applies to AI/machine learning models which are not relevant here.
9. How the ground truth for the training set was established:
- Not Applicable. This applies to AI/machine learning models which are not relevant here.
§ 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.