(48 days)
Textured Powder-Free Latex Exam Glove with Aloe Vera and Protein Content Labeling Claim, Green is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Textured Powder-Free Latex Exam Gloves With Aloe Vera Green, contains 50 mcgm or less of total water extractable protein per gram
This is a letter about a medical device, specifically Textured Powder-Free Latex Examination Gloves With Aloe Vera Green. The letter is a 510(k) premarket notification approval from the FDA.
Based on the provided text, there is no study described that proves the device meets acceptance criteria. The letter is an approval letter based on substantial equivalence to a previously marketed device, not a detailing of a specific study or performance metrics.
Therefore, most of the requested information cannot be extracted from this document as it doesn't contain a detailed study report. Here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary acceptance criterion mentioned is the "Labeling Claim, Green Cortforms . 50 million on less prefern per gram" (likely a typo and meant to be "50 micrograms or less of total water extractable protein per gram").
- Reported Device Performance: The document only states that the device "conforms" to this claim. No numerical performance results from a specific test are provided within this letter.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified in this document.
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)
- Not specified in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in this document.
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/Not specified in this document. This device is a glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified in this document. This device is a glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here would relate to the protein content testing. It's implied that a standardized chemical test method would have been used to determine the total water extractable protein per gram. No specifics are given.
8. The sample size for the training set
- Not applicable/Not specified in this document. This isn't a machine learning model.
9. How the ground truth for the training set was established
- Not applicable/Not specified in this document.
§ 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.