(6 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.
Dental Powder-Free Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.
Here's a breakdown of the acceptance criteria and study information for the Dental Powder-Free Latex Examination Gloves with Protein Labeling Claim, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | No potential for irritation | Gloves do not display any potential for irritation. |
| Guinea Pig Maximization (Sensitization) | No potential for sensitization | Gloves do not display any potential for irritation. |
| Ultimate Elongation & Tensile Strength | Meet or exceed requirements per ASTM D3578-01 | Gloves meet or exceed requirements for rubber examination gloves per ASTM D3578-01. |
| Barrier Defects | Meet or exceed requirements per 21 CFR §800.20 and ASTM D3578-01 | Gloves meet or exceed requirements per 21 CFR §800.20 and ASTM D3578-01. |
Note: The acceptance criteria for "Primary Skin Irritation" and "Guinea Pig Maximization" are implicitly derived from the reported results, as the document states the gloves "do not display any potential for irritation" (which, for Guinea Pig Maximization, typically implies no sensitization).
Regarding the device and study described, it's important to note the following based on the provided text:
This submission is for a medical device (examination gloves), not a diagnostic AI/imaging algorithm. Therefore, many of the requested categories related to AI studies, like MRMC studies, ground truth establishment by experts, and training/test set details, are not applicable to this type of device. The "study" here refers to standard performance testing for a physical product.
Here's an attempt to address the remaining points as best as possible given the nature of the device:
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text for any of the tests. Standard ASTM and regulatory testing typically involves specific sample sizes, but these are not disclosed here.
- Data Provenance: Not explicitly stated. For physical product testing, this typically means the samples were manufactured and then tested according to established protocols. It is assumed to be prospective, as the testing was done on the device prior to marketing approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For physical product testing like gloves, "ground truth" is established through standardized laboratory tests (e.g., measuring tensile strength using a machine, or observing skin reactions in animal models), not by human experts interpreting data.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of data (e.g., medical images). For physical product testing, results are objective measurements or observations during laboratory procedures.
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-assisted diagnostic device, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For Ultimate Elongation & Tensile Strength and Barrier Defects: The "ground truth" is based on the objective physical and chemical properties of the glove as measured by standardized industrial and regulatory test methods (ASTM D3578-01, 21 CFR §800.20).
- For Primary Skin Irritation and Guinea Pig Maximization: The "ground truth" is based on the biological response of test subjects (e.g., animals for sensitization, human volunteers for irritation if not animal-based) under controlled laboratory conditions.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no training set for this type of device.
§ 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.