(23 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.
Nitrile Exam Gloves, Powder-Free, Blue
This document is a 510(k) summary for a Nitrile Exam Glove, Powder-Free, Blue. It is a medical device submission, and the content provided does not relate to an AI/ML powered device or a study demonstrating its performance. Therefore, I cannot fulfill your request for detailed information about acceptance criteria, study design, and AI-specific metrics like MRMC studies or human reader improvement, as these concepts are not applicable to the provided document.
The document discusses the substantial equivalence of the Nitrile Exam Glove to already marketed devices based on physical characteristics and intended use. The "Test Results" section (K980802 on page 34 of 34) lists the standards and tests that the device has met or exceeded, which serve as the acceptance criteria for the glove's performance.
Here's a breakdown of the information that can be extracted relevant to your request, adapted for a non-AI medical device submission:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Standards/Tests Met) | Reported Device Performance |
|---|---|
| ASTM D 3578-95 | Met or exceeded |
| ASTM D 5151 | Met or exceeded |
| FDA Water Leak Test (before & after aging) | Met or exceeded |
| Nitrile Glove Draft ASTM, Sept 97 | Met or exceeded |
| Bio-Compatibility Dermal Sensitization | Met or exceeded |
| Primary Skin Irritation | Met or exceeded |
| Bio-Burden (bacteria/mold) | Met or exceeded |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes used for each test. For medical devices like gloves, testing is typically done on representative batches according to the specified ASTM standards.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted on the manufacturer's product (Sinochem Ningbo Latex Gloves Factory). The document does not specify country of origin for the data itself, but the device is manufactured by Sinochem Ningbo Latex Gloves Factory, implying the testing was done on their product. It is a retrospective evaluation of the product's compliance with established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not directly applicable to the testing of examination gloves. The "ground truth" here is adherence to objective, standardized test methodology and performance thresholds defined by organizations like ASTM and the FDA. The experts involved would be the certified laboratory technicians and engineers performing these specific tests, adhering to the standard protocols. Their qualifications would be in laboratory practices and materials testing, not medical diagnosis or interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Performance testing for medical gloves involves 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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" is defined by the objective performance criteria specified in the referenced ASTM standards and FDA guidelines (e.g., specific tensile strength, elongation, water leak rate, biocompatibility thresholds).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device. There is no concept of a "training set" in the context of standard physical and biocompatibility testing for medical gloves.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.