(94 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are dark blue, powder free, nitrile ambidextrous gloves with a beaded cuff. The gloves are offered in sizes small, medium, large, and extra extra extra large packaged in a chipboard box.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs).
This document outlines the substantial equivalence review for a medical device (examination gloves), not an AI/ML powered device. Therefore, many of the requested categories related to AI performance, such as sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies, are not applicable.
The core of the acceptance criteria and study in this submission revolves around the physical properties and barrier efficacy of the gloves, particularly against chemotherapy drugs.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Standard/Requirement) | Reported Device Performance (Reference) |
|---|---|---|
| Physical Properties | ASTM D6319-10 Compliance | Complies with ASTM D6319-10: |
| - Dimensions (Width) | 70mm min | 70mm min |
| - Dimensions (Thickness) | Palm - 0.05mm min. | |
| Finger - 0.05mm min. | Palm - 0.05mm min. | |
| Finger - 0.05mm min. | ||
| - Tensile Strength | Before Aging ≥14 MPa, min. | |
| After Aging ≥14 MPa, min. | Before Aging ≥14 MPa, min. | |
| After Aging ≥14 MPa, min. | ||
| - Elongation | Before Aging 500%, min. | |
| After Aging 400%, min. | Before Aging 500%, min. | |
| After Aging 400%, min. | ||
| Freedom from Holes | ASTM D6319-10 and ASTM D5151-06 (G-1, AQL 1.5) | Complies with ASTM D6319-10 and ASTM D5151-06 G-1, AQL 1.5 |
| Residual Powder | **ASTM D6319-10 (240 minutes |
- Cyclophosphamide: >240 minutes
- Dacarbazine: >240 minutes
- Doxorubicin HCl: >240 minutes
- Etoposide: >240 minutes
- Fluorouracil: >240 minutes
- Methotrexate: >240 minutes
- Mitomycin C: >240 minutes
- Paclitaxel: >240 minutes
- ThioTepa: 27.4 minutes
- Vincristine Sulfate: >240 minutes
Labeling restriction: Do Not Use with Carmustine or Thiotepa |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of gloves) used for each individual test (e.g., tensile strength, hole detection, each chemotherapy drug). It references adherence to ASTM standards, which would dictate the sample sizes and testing methodologies. The data provenance is implied to be from laboratory testing conducted on the manufactured gloves. It is prospective in the sense that the testing was performed specifically for this submission on the device being reviewed. The country of origin of the data is not specified, but the testing standards (ASTM, ISO) are international/US-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for glove performance is established by standardized laboratory testing methods (ASTM, ISO). Expert interpretation of images or clinical data is not relevant here.
4. Adjudication method for the test set
Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, not for objective laboratory physical and chemical barrier testing.
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 a medical device for physical protection, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
The "ground truth" is defined by the objective measurements obtained through standardized laboratory tests (e.g., physical dimensions, strength, and chemical permeation) as dictated by the referenced ASTM and ISO standards. For chemotherapy permeation, the "breakthrough time" measured according to ASTM D6978-05 served as the direct performance metric.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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.