(99 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.
This document describes the acceptance criteria and the study proving that the "Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)" meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The device was tested against several standards, as detailed in the "Summary of Non-Clinical Testing" section (pages 8-13). Here's a summary:
| No. | Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 1 | ISO 10993-10:2010 (Skin Sensitization) | Grades less than 1. | All grades were 0. All animals survived with no abnormal signs. The device is not a sensitizer. |
| 2 | ISO 10993-10:2010 (Skin Irritation) | Primary irritation index of 0-0.4 for "Negligible" response. | The primary irritation index was 0. The response was categorized as negligible. The device is not an irritant. |
| 3 | ISO 10993-5:2009 (In Vitro Cytotoxicity) | Viability ≥ 70% of the blank (if viability is reduced to 240 Minutes | |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | |||
| Dacarbazine 10 mg/ml: > 240 Minutes | |||
| Doxorubicin HCl 2.0 mg/ml: > 240 Minutes | |||
| Etoposide 20.0 mg/ml: > 240 Minutes | |||
| Fluorouracil 50.0 mg/ml: >240 Minutes | |||
| Methotrexate, 25 mg/ml: >240 Minutes | |||
| Mitomycin C, 0.5 mg/ml: >240 Minutes | |||
| Paclitaxel 6.0 mg/ml: >240 Minutes | |||
| Thio Tepa 10.0 mg/ml: 37.4 Minutes (min.) | |||
| Vincristine Sulfate, 1mg/ml: >240 Minutes |
2. Sample Size Used for the Test Set and Data Provenance:
The document provides the following details:
- ASTM D5151 (Freedom from Holes): Sample size of 125 gloves. The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated but is implied to be from laboratory testing conducted as part of the regulatory submission process.
- For other tests (Biocompatibility, Physical Properties, Chemotherapy Drug Permeation), specific sample sizes are not detailed in the provided text. However, testing was stated to be "in accordance with the following standards" (ISO and ASTM), which would implicitly define minimum sample sizes for each test method. Data provenance is implied to be from laboratory testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The tests conducted are laboratory-based and follow established international and national standards (ISO, ASTM). The "ground truth" for these tests is defined by the methodologies and performance requirements within these standards, not by expert consensus in a clinical sense.
4. Adjudication Method for the Test Set:
This information is not applicable as the tests are laboratory performance tests following well-defined standards, not clinical studies requiring independent adjudication of outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable as the device is a medical glove, and the studies are pre-market non-clinical performance and biocompatibility evaluations. It is not an AI-assisted diagnostic device or a device where human reader performance would be a relevant metric.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable as the device is a medical glove, not an algorithm or AI system. The performance evaluated is the physical and chemical resistance of the glove itself.
7. Type of Ground Truth Used:
The ground truth for the evaluations is based on:
- Standardized Laboratory Test Results: Defined by the methodologies and acceptance criteria specified in the referenced ASTM and ISO international standards (e.g., specific tensile strength values, breakthrough times, chemical concentrations).
- Biocompatibility Endpoints: As defined by ISO 10993 standards (e.g., absence of irritation, sensitization, systemic toxicity).
8. Sample Size for the Training Set:
This information is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information 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.