(296 days)
This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below
| Minimum Breakthrough detection time (minutes) | |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.9 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine (100mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 11.1 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Do not use with Carmustine and Thiotepa.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15.9 minutes and Thiotepa:11.1 minutes.
The Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D6319-10. It is an ambidextrous medical glove, which is a disposable device, provided in x-small, medium, large and xlarge sizes. In addition, these gloves were tested for use with chemotherapy drugs per ASTM D6978-05 "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug," and Modified-Draize-95 Test, per FDA guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products," 1999.
The provided text describes the acceptance criteria and performance of a medical device, specifically a "Powder-free Nitrile Patient Examination Glove." This document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device.
It's important to note that this document does not describe an AI/ML medical device. The "device" in question is a physical glove, and the "tests" are for its physical properties and chemical resistance, not for an algorithm's performance on a dataset. Therefore, many of the requested fields related to AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this document.
However, I can extract the relevant information regarding the acceptance criteria and how the glove's performance was proven based on the provided text.
Acceptance Criteria and Device Performance (for a physical medical glove)
The document primarily focuses on demonstrating that the subject device (the green nitrile glove) is substantially equivalent to a predicate device (blue or white nitrile gloves) by meeting established standards for patient examination gloves and resistance to chemotherapy drugs.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Standard Reference and/or General Expectation) | Reported Device Performance | Comments on Meeting Criteria |
|---|---|---|---|
| Dimensions | ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) - max allowable defective samples met | "The number of defective samples was 0" | Meets |
| Tensile Strength | ASTM D6319-10 - max allowable defective samples met | "The number of defective samples was 0" | Meets |
| Residual Powder | ASTM D6319-10 - max allowable defective samples met | "The number of defective samples were 0" | Meets |
| Water Leak Test | ASTM D6319-10 - max allowable defective samples met (2 per lot) | "In three of the five lots, the number of defective samples was 1; less or equal than the maximum allowable. In two of the three lots, the number of defective samples was zero." | Meets |
| Low Dermatitis Potential (Modified Draize Test) | No clinical evidence of residual chemical additives inducing Type IV allergy in un-sensitized general user populations | "no clinical evidence of the presence of residual chemical additives that may induce Type IV allergy..." | Meets |
| Chemotherapy Drug Permeation (ASTM D6978-05) | Specific breakthrough times for various chemotherapy drugs, ideally >240 minutes for safe use. | See detailed table below. | Meets for most drugs, with specific warnings for Carmustine and Thiotepa due to low breakthrough times. |
| Biocompatibility (Cytotoxicity) | ANSI/AAMI/ISO 10993-5 compliant | "Cytotoxicity compliant as per ANSI/AAMI/ISO 10993-5:2009/(R)2014" | Meets |
| Biocompatibility (Irritation/Sensitization) | ISO 10993-10 compliant | "irritation/sensitization...successfully tested in accordance with ISO 10993-10 Third Edition 2010-08-01" | Meets |
Chemotherapy Drug Permeation Specifics (from "Indications for Use" and "Technological Characteristics" tables):
| Chemotherapy Drug | Acceptance Criteria (Predicate Device) - Minimum Breakthrough detection time (minutes) | Reported Device Performance (Subject Device) - Minimum Breakthrough detection time (minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 10.4 | 15.9 |
| Cisplatin (1.0 mg/ml) | >240 | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 | >240 |
| Cytarabine (100mg/ml) | >240 | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | >240 |
| Etoposide (20.0 mg/ml) | >240 | >240 |
| Fluorouracil (50.0 mg/ml) | >240 | >240 |
| Ifosfamide (50.0 mg/ml) | >240 | >240 |
| Methotrexate (25.0 mg/ml) | >240 | >240 |
| Mitomycin C (0.5 mg/ml) | >240 | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 | >240 |
| Thiotepa (10.0 mg/ml) | 90.5 | 11.1 |
| Vincristine Sulfate (1.0 mg/ml) | >240 | >240 |
Important Note: The document explicitly states "Do not use with Carmustine and Thiotepa" due to their extremely low permeation times, even though the subject device still improved upon Carmustine's breakthrough time compared to the predicate.
Regarding the AI/ML-specific questions (which are not applicable to this physical glove device):
- Sample sizes used for the test set and the data provenance: Not applicable. Testing was on physical glove samples from various production lots, not on a dataset in the AI/ML context. Data provenance is implied to be from the manufacturer's testing of their product.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (e.g., hole in glove, chemical permeation) is established through standardized laboratory tests, not human expert consensus. "Experts" would be laboratory technicians or chemists.
- Adjudication method for the test set: Not applicable. Laboratory tests follow predefined protocols; no human adjudication is mentioned or implied for test results.
- 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 physical device, not an AI/ML algorithm.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
- The type of ground truth used: For physical and chemical tests, the ground truth is objective measurement against established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. For biocompatibility, it's the biological response in standardized in-vitro or in-vivo (human repeat insult patch testing) models.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- 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.