(71 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.
POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES, Class I Device, 80LZA
The provided document is a 510(k) summary for Powder-Free Lavender/Purple Nitrile Exam Gloves. It details the device's characteristics and its equivalence to previously marketed devices. However, it does not describe specific acceptance criteria in the typical sense of a detailed performance study with defined thresholds for sensitivity, specificity, accuracy, etc., which would be expected for a diagnostic or AI-driven device.
Instead, the "acceptance criteria" for this device are framed as compliance with recognized ASTM standards and biocompatibility tests, which are pass/fail criteria for material properties and safety. The "study" proving the device meets these criteria is the performance of these tests, demonstrating compliance.
Here's the breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 3578-00 | Met or exceeded |
| ASTM D 5712-00 | Met or exceeded |
| ASTM D 6124-00 | Met or exceeded |
| ASTM D 5151-00 | Met or exceeded |
| ASTM F 1671 | Met or exceeded |
| ASTM F 1383 | Met or exceeded |
| ASTM F 903 | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Bio-Compatibility: Primary Skin Irritation | Met or exceeded |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each ASTM test or biocompatibility test. It also does not explicitly state the country of origin of the data for these tests or if they were retrospective or prospective. It can be inferred that these tests were conducted on samples of the manufactured gloves by the applicant (SHEEN MORE ENTERPRISE CO., LTD. in Taiwan R.O.C.) or a testing facility contracted by them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the evaluation of examination gloves. The "ground truth" for these types of devices is established through adherence to standardized laboratory test methods (e.g., tensile strength, tear resistance, barrier integrity, biocompatibility), not through expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The evaluation of these gloves against ASTM standards and biocompatibility involves objective laboratory measurements and standardized protocols, not human adjudication of subjective interpretations.
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
This is not applicable as the device is a medical glove, not an AI-assisted diagnostic tool or a device requiring human reader interpretation in its primary function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product (medical glove) and does not involve any algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on the standards and specifications outlined in the ASTM test methods and biocompatibility guidelines. These standards define the acceptable physical properties (e.g., tensile strength, elongation, puncture resistance) and biological responses (e.g., lack of irritation or sensitization) for patient examination gloves.
8. The sample size for the training set
This is not applicable as the device is a physical product and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical product and does not involve an algorithm or a 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.