(391 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.
Powder Free Black Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
This document is a 510(k) Pre-Market Notification for a Powder Free Black Nitrile Examination Glove (K201428) and does not describe a study involving an AI/ML powered device. Instead, it details the substantial equivalence of the new nitrile glove to a predicate device (K153562) based on non-clinical performance and biological safety testing.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, or MRMC studies.
However, I can extract the acceptance criteria and reported performance for the nitrile examination glove based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance (for the Nitrile Examination Glove):
| Characteristic/Parameter | Acceptance Criteria (Predicate or Standard) | Reported Performance (Proposed Device K201428) | Discussion / Outcome |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Intended Use | To prevent contamination between patient and examiner | To prevent contamination between patient and examiner | Same |
| Classification | Class 1 | Class 1 | Same |
| Raw Rubber Material | Nitrile (Acrylonitrile-butadiene) | Nitrile (Acrylonitrile-butadiene) | Same |
| Surface Appearance | Blue, Ambidextrous, Finger Textured (Predicate) | Black, Ambidextrous, Finger Textured | Different color; same design/texture |
| Freedom of Holes | Meet AQL 1.5 at G1 (Predicate) / AQL 2.5 at G1 (ASTM) | Meet AQL 1.5 with G1 | Similar |
| Overall Length | Minimum 230mm | Average: 242mm | Similar |
| Width (S, M, L) | S: 75-95mm, M: 85-105mm, L: 100-120mm | S: 85mm, M: 95mm, L: 104mm (Average) | Similar (Meeting specification) |
| Palm Thickness | Minimum 0.05mm | Average: 0.06mm | Similar |
| Finger Thickness | Minimum 0.05mm | Average: 0.11mm | Similar |
| Tensile Strength (before age) | Minimum 14 MPa | Average: 17.44 MPa | Similar |
| Tensile Strength (after age) | Minimum 14 MPa | Average: 16.37 MPa | Similar |
| Ultimate Elongation (before age) | Minimum 500% | Average: 559% | Similar |
| Ultimate Elongation (after age) | Minimum 400% | Average: 508% | Similar |
| Residual Powder Test | Less than 2mg/glove | S: 0.43 mg/glove, M: 0.31 mg/glove, L: 0.47 mg/glove (Average) | Similar (Contained less than 2mg/glove) |
| Primary Skin Irritation | Not an irritant | Under the conditions of study, not an irritant | Similar |
| Dermal Sensitization | Not a sensitizer | Under the conditions of study, not a sensitizer | Similar |
| Cytotoxicity | N/A (Predicate) | Not Cytotoxic | Different (Pred. info N/A) |
| Acute Systemic Toxicity | N/A (Predicate) | Not induce systemic toxicity | Meeting requirements per ISO 10993-11 |
As there is no AI/ML component to the device described in this document, the following points are not applicable:
2. Sample size used for the test set and the data provenance: Not applicable. (Performance claims are based on physical and biological tests of the glove material, not a data-driven test set.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (Ground truth not established in the context of an AI/ML test set.)
4. Adjudication method 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of AI/ML. For the glove, the "ground truth" or reference for performance is established by ASTM standards and ISO biological evaluation guidelines.
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.