(62 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.
Class 1 vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92.
This document (K992107) describes a submission for "GG" vinyl examination gloves, powder-free, from General Gloves Corp. It is a 510(k) summary, which indicates it's for claiming substantial equivalence to a legally marketed device rather than a de novo approval requiring extensive clinical trials.
Therefore, the document does not contain information about a study proving the device meets acceptance criteria in the way one would expect for a novel medical device like an AI-powered diagnostic tool. Instead, it demonstrates compliance with a recognized standard and compares the device's characteristics to a predicate device.
Here's an analysis based on the provided text, addressing your points where applicable, and noting when the information is not present in this type of submission:
1. Table of acceptance criteria and the reported device performance
The acceptance criteria are generally derived from the ASTM D 5250 - 92 standard for patient examination gloves. The reported device performance is stated to meet or exceed these standards.
| Acceptance Criteria (from ASTM D 5250 - 92) | Reported Device Performance (GG vinyl examination gloves powder-free) |
|---|---|
| Dimension and Tolerance (S-2, AQL 4.0) | |
| Width (S) | 85-87 mm (+5 to +3 tolerance) |
| Width (M) | 95-97 mm (+5 to +3 tolerance) |
| Width (L) | 105-107 mm (+5 to +3 tolerance) |
| Width (XL) | 115-117 mm (+5 to +3 tolerance) |
| Length (all sizes) | 230 mm min. |
| Physical Requirements (Before and after accelerated aging 70 + 2 C for 72 + 2 hours, acc. to D573; Inspection level S-2, AQL 4.0) | |
| Ultimate Elongation (%, min) | 300% |
| Tensil strength (Mpa, min) | 9.0 Mpa |
| Pinhole requirements | Meets FDA pinhole requirements. |
| Biocompatibility | Data conducted on powdered vinyl gloves (presumably applicable or similar to powder-free version). |
| Labeling claims | Meets labeling claims. |
2. Sample size used for the test set and the data provenance
The document mentions "inspection level S-2, AQL 4.0" for dimension/tolerance and physical requirements. These are sampling plans from standards, but the exact sample size (number of gloves tested from a batch) is not explicitly stated in the summary, as it depends on the lot size.
The data provenance is from Taiwan (Tung Chung Village, Tung Shan Hsian, Tainan Hsien, Taiwan, R.O.C.), where General Gloves Corp. is located. The tests would be considered prospective manufacturing quality control tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided for this type of device submission. Glove testing relies on standardized physical and chemical tests, not expert interpretation of outputs.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically associated with subjective assessments or diagnostic studies. Glove testing involves objective measurements based on established standards.
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 information is not applicable. This is a submission for an examination glove, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This information is not applicable. This is a submission for an examination glove, not an algorithm.
7. The type of ground truth used
The "ground truth" here is compliance with the ASTM D 5250 - 92 standard for patient examination gloves and FDA pinhole requirements. This is based on objective, quantifiable physical and chemical properties of the gloves.
8. The sample size for the training set
This information is not applicable. This is a physical product (glove), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As above, it's not an AI/ML device requiring a training set. The "ground truth" for glove quality is established by adherence to a recognized international standard (ASTM D 5250 - 92).
§ 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.