(21 days)
The Nitrile Powder-Free Medical Examination Glove (brown) is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).
Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens. Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.
The provided document is a 510(k) submission for a medical examination glove, which is a low-risk device. The regulatory requirements for such devices typically focus on demonstrating substantial equivalence to a predicate device through non-clinical and, in some cases, limited clinical testing, rather than extensive studies with acceptance criteria, human reader performance, or detailed ground truth establishment as would be required for more complex diagnostic AI devices.
Therefore, many of the requested categories for AI-based device studies are not applicable to this submission.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Specification | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Non-Clinical Tests | ||
| Performance Standards | ASTM (met by predicate N-DEX Nitrile Powder-Free Medical Examination Glove (blue) & HPI Brown Nitrile Surgical Glove) | ASTM (met) |
| Watertightness | ASTM (met by predicate N-DEX Nitrile Powder-Free Medical Examination Glove (blue) & HPI Brown Nitrile Surgical Glove) | ASTM (met) |
| Clinical Tests (Biocompatibility) | ||
| Rabbit Irritation | Passes (met by predicate) | Passes |
| Guinea Pig Sensitization | Passes (met by predicate) | Passes |
| Modified Draze Test (Human Study) | Passes (met by predicate K992170) | N/A (not performed on proposed device) |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a non-clinical and limited clinical (biocompatibility) comparison study against two predicate devices: N-DEX Nitrile Powder-Free Medical Examination Glove (K992170) and HPI Brown Nitrile Surgical Glove (K915086). The submission claims that the proposed device "meets or exceeds accepted scores for the predicate product in both physical and non-clinical tests."
Detailed Information for AI-based Device Categories (Not Applicable / Information Not Provided for this Medical Glove Submission):
- 2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples of the glove material itself, subjected to physical and chemical tests (e.g., for watertightness, irritation). The document doesn't specify the number of gloves sampled for these tests, nor the "country of origin of the data" in the context of user data. This is a medical device, not a data-driven AI device.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical medical device like this is established through standardized test methods (e.g., ASTM standards for glove performance, animal/human studies for biocompatibility). It doesn't involve expert consensus on image interpretation or similar AI-related tasks.
- 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 device.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by standardized physical tests (e.g., ASTM for watertightness, tensile strength - though tensile strength isn't explicitly listed in the summary table but implied by "performance standards") and biocompatibility testing using animal models (rabbit irritation, guinea pig sensitization) and a human study for skin sensitivity (Modified Draze Test on the predicate).
- 8. The sample size for the training set: Not applicable.
- 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.