(187 days)
An 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.
Non-sterile examination glove
This document is a 510(k) clearance letter from the FDA for a medical device: "Regent Biogel Diagnostic Powder-Free Examination Glove with Protein Content Labeling Claim of 50 Micrograms or less".
This type of device (an examination glove) does not typically have acceptance criteria and a study to prove performance in the same way that a diagnostic algorithm or a complex medical instrument would. The clearance is based on substantial equivalence to predicate devices, and the "acceptance criteria" here relate to meeting regulatory standards and the specific protein content claim.
Therefore, many of the requested fields are not applicable to this document. I will fill in what can be inferred or directly stated.
Acceptance Criteria and Device Performance Study for Regent Biogel Diagnostic Powder-Free Examination Glove
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to legally marketed predicate devices. | The FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976. |
| Protein Content Labeling Claim: 50 Micrograms or less. | The device's trade name includes "with Protein Content Labeling Claim of 50 Micrograms or less." The FDA clearance implies this claim was substantiated for regulatory purposes. (Specific test results are not detailed in this letter.) |
| Compliance with general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). | The device is cleared for marketing "subject to the general controls provisions of the Act." The FDA assumes compliance with the Quality System Regulation (21 CFR Part 820) which covers GMP. |
| Intended Use: Disposable device for medical purposes, worn on examiner's hand/finger to prevent contamination between patient and examiner. | The "Indications for Use" explicitly state this purpose. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable for this 510(k) clearance letter. This document does not detail specific performance studies with test sets in the context of diagnostic or algorithmic performance. The clearance is based on substantial equivalence and regulatory compliance.
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 applicable. This device is not evaluated by experts for "ground truth" in the diagnostic sense. The FDA's evaluation is by regulatory experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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-assisted device or a diagnostic device involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this type of device is primarily based on:
- Regulatory Standards Compliance: Adherence to established FDA regulations (e.g., general controls, Quality System Regulation).
- Performance Benchmarking to Predicate Devices: Demonstrating that the device is as safe and effective as a legally marketed predicate device (which would have its own established performance characteristics, often related to physical properties like tensile strength, barrier integrity, and protein content).
- Manufacturer's Internal Testing: The manufacturer would have conducted tests to substantiate the protein content claim and other performance characteristics, which are reviewed by the FDA during the 510(k) process, but the detailed results are not in this letter.
8. The sample size for the training set
Not applicable. This is not a machine learning or diagnostic device that uses a "training set."
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.