(57 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Disposable Powder Free Vinyl Exam Glove, Blue Color
The provided text is a 510(k) premarket notification letter from the FDA regarding a Disposable Powder Free Vinyl Exam Glove, Blue Color. This document is for a Class I medical device and describes its intended use and regulatory classification.
The information requested in the prompt, such as acceptance criteria, details of a study with sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, are typically associated with performance validation of more complex devices, particularly those involving algorithms, diagnostics, or therapeutic effects.
This document does not contain the type of detailed performance study information requested.
Here's why and what can be extracted:
- Device Type: Exam gloves are Class I devices, meaning they pose the lowest risk to patients and users. Their substantial equivalence is typically demonstrated through compliance with recognized standards (e.g., for strength, leak resistance, biocompatibility) rather than complex comparative effectiveness studies or algorithm performance evaluations.
- Regulatory Focus: The FDA letter primarily confirms "substantial equivalence" to a legally marketed predicate device, allowing the introduction of the device to the market under general controls. It's about regulatory clearance, not detailed performance validation in the way one would see for an AI-powered diagnostic tool.
Therefore, I cannot populate the table or answer most of the questions using only the provided text.
However, I can extract the following limited information relevant to the prompt:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document implies that the acceptance criteria for this device are its substantial equivalence to a legally marketed predicate device, as well as compliance with general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration). Specific performance metrics (e.g., tensile strength, barrier integrity) would be part of the underlying submission that led to this letter, but are not detailed here.
- Reported Device Performance: The letter states the FDA "determined the device is substantially equivalent," meaning it met the necessary criteria for regulatory clearance. Again, specific performance metrics are not listed in this public face page.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial Equivalence to Predicate | Determined to be substantially equivalent. |
| Compliance with general controls | Assumed to be met for clearance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated in this document. For a Class I device like gloves, testing typically involves standardized material and physical property tests, not clinical "test sets" in the diagnostic sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. This type of information is usually relevant for diagnostic devices that require expert interpretation or consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not stated.
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:
- No. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for this type of device based on the document. Ground truth for gloves usually revolves around manufacturing standards and material properties (e.g., results of leak tests, tensile strength tests, biocompatibility tests).
8. The sample size for the training set:
- Not applicable/Not stated.
9. How the ground truth for the training set was established:
- Not applicable/Not stated.
§ 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.