(45 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.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, green colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in five sizes, extra-small, small, medium, large and extra-large.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013).
The provided text details a 510(k) premarket notification for a medical device, specifically Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs). It outlines the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, focusing on physical properties, biocompatibility, and chemotherapy drug permeation.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting established ASTM standards for examination gloves and demonstrating resistance to chemotherapy drug permeation. The reported device performance is presented as compliance with these standards and specific breakthrough times for chemotherapy drugs.
| Test / Performance Metric | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Physical Performance | ||
| Dimensions (Length) | Complies with ASTM D6319-10: 220mm min. | Complies with ASTM D6319-10: 220mm min. |
| Dimensions (Width) | Complies with ASTM D6319-10 (X-small – 70±10mm, Small – 80±10mm, Medium – 95±10mm, Large – 110±10mm, X-large – 120±10mm) | Complies with ASTM D6319-10 (X-small – 70±10mm, Small – 80±10mm, Medium – 95±10mm, Large – 110±10mm, X-large – 120±10mm) |
| Dimensions (Thickness) | Complies with ASTM D6319-10 (Palm – 0.05mm min., Finger – 0.05mm min.) | Complies with ASTM D6319-10 (Palm – 0.05mm min., Finger – 0.05mm min.) |
| Physical Properties (Tensile Strength) | Complies with ASTM D6319-10: | |
| Before Aging ≥14 MPa, min. | ||
| After Aging ≥14 MPa, min. | Complies with ASTM D6319-10: | |
| Before Aging ≥14 MPa, min. | ||
| After Aging ≥14 MPa, min. | ||
| Physical Properties (Elongation) | Complies with ASTM D6319-10: | |
| Before Aging 500%, min. | ||
| After Aging 400%, min. | Complies with ASTM D6319-10: | |
| Before Aging 500%, min. | ||
| After Aging 400%, min. | ||
| Freedom from Holes | Complies with 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 | Complies with ASTM D6319-10: 240 minutes where possible. | Carmustine (BCNU) 3.3 mg/ml: 13.2 minutes |
| Cisplatin 1.0 mg/ml: >240 minutes | ||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: >240 minutes | ||
| Dacarbazine (DTIC) 10.0 mg/ml: >240 minutes | ||
| Doxorubicin Hydrochloride 2.0 mg/ml: >240 minutes | ||
| Etoposide (Toposar) 20.0 mg/ml: >240 minutes | ||
| Fluorouracil 50.0 mg/ml: >240 minutes | ||
| Methotrexate 25.0 mg/ml: >240 minutes | ||
| Mitomycin C 0.5 mg/ml: >240 minutes | ||
| Paclitaxel (Taxol) 6.0 mg/ml: >240 minutes | ||
| Thiotepa 10.0 mg/ml: 44.0 minutes | ||
| Vincristine Sulfate 1.0 mg/ml: >240 minutes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of gloves or individual test replicates) used for each of the physical, biocompatibility, and permeation tests. The data provenance is derived from non-clinical bench testing performed on the device. No information is provided regarding the country of origin or if it's retrospective/prospective outside of standard laboratory practices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the review is for a medical glove, which is evaluated through objective physical, chemical, and biological performance tests against recognized standards, not by human expert opinion or interpretation of data in the same way an AI diagnostic device would be. The "ground truth" for these tests is established by the test methodologies themselves within the ASTM and ISO standards.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. The evaluation relies on standardized test results rather than expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient data (e.g., medical images) and an AI's impact on their performance is being evaluated. This document concerns a medical glove, which is evaluated through bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The performance evaluation of the medical glove (physical properties, biocompatibility, and chemotherapy permeation) is inherently a "standalone" evaluation of the device itself, without human interpretation in the context of a diagnostic task. The device's performance is measured directly through standardized tests against predefined criteria. There is no AI algorithm being evaluated here.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by recognized industry standards and test methodologies.
- Physical Performance: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves). These standards define the acceptable range of physical properties.
- Biocompatibility: ANSI/AAMI/ISO 10993-10 (Biological Evaluation of Medical Devices-Part 10: Tests for irritation and skin sensitization). These define acceptable biological responses.
- Chemotherapy Drug Permeation: ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs). This standard defines the method for measuring breakthrough times.
8. The Sample Size for the Training Set
This section is not applicable. This submission is for a physical medical device (gloves), not an artificial intelligence or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
§ 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.