(88 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. For Medical Use
Uni-Gloves Brand Patient Examination Glove (Powder-Free)
Here is the information you requested based on the provided document:
This document is a 510(k) clearance letter from the FDA for a medical device (Unigloves Powder Free Latex Examination Gloves). This type of document typically does not contain detailed studies on acceptance criteria or device performance data, as it's a clearance for substantial equivalence to a predicate device, not a new device approval requiring extensive clinical trial results. Therefore, many of your requested items cannot be definitively answered from this letter.
However, I can extract the information that is present and indicate where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in this document. The letter refers to "substantial equivalence" to predicate devices, implying performance meets baseline medical device standards. | Not explicitly stated in this document. The letter does not include performance data or studies. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not available in this document.
- Data provenance: Not available 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)
- Number of experts: Not available in this document.
- Qualifications of experts: Not available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available 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
- This device is a physical medical device (examination gloves), not an AI or imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a physical medical device (examination gloves), not an algorithm or software. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available in this document. For devices like examination gloves, "ground truth" often relates to material properties (e.g., tensile strength, barrier integrity) and biocompatibility, which would be tested against established standards rather than clinical "ground truth" like pathology.
8. The sample size for the training set
- Not applicable/Not available. This document pertains to a physical medical device, not a machine learning model, so there is no "training set" in the computational sense.
9. How the ground truth for the training set was established
- Not applicable/Not available. As above, there is no "training set" for this type of device.
Summary of what the document does provide:
- Device Name: Unigloves Powder Free Latex Examination Gloves
- Regulatory Class: I
- Product Code: LYY
- Indications For Use: "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."
- Regulatory Status: Substantially Equivalent (K971731) to predicate devices marketed prior to May 28, 1976.
- Use Type: Over-The-Counter Use X (as specified in the enclosure)
§ 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.