(219 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
This glove was tested for use with chemotherapy drugs and Fentanyl Citrate as pet ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
This document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim." The core of the submission revolves around demonstrating the glove's resistance to permeation by chemotherapy drugs and Fentanyl.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Nitrile Powder Free Examination Glove's resistance to chemotherapy drugs and Fentanyl permeation are based on the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is the "Minimum breakthrough Detection Time (min)" for each chemical.
| No | Test Chemotherapy Drug | Concentration (mg/ml) | Acceptance Criteria (Implicit from context: generally, higher is better, and values over 240 mins are good, though specific pass/fail thresholds are not explicitly stated as 'acceptance criteria' in the common sense, rather the demonstration of resistance) | Reported Device Performance (Minimum breakthrough Detection Time (min)) |
|---|---|---|---|---|
| 1 | Amethopterin | 25 | Resistance to permeation | >240 |
| 2 | Bleomycin Sulfate | 15 | Resistance to permeation | >240 |
| 3 | Busulfan | 6 | Resistance to permeation | >240 |
| 4 | Carboplatin | 10 | Resistance to permeation | >240 |
| 5 | Carmustine | 3.3 | Resistance to permeation (Note: Explicit warning given due to low permeation time) | 11.0 |
| 6 | Cisplatin | 1 | Resistance to permeation | >240 |
| 7 | Cyclophosphamide | 20 | Resistance to permeation | >240 |
| 8 | Cytarabine | 100 | Resistance to permeation | >240 |
| 9 | Dacarbazine | 10 | Resistance to permeation | >240 |
| 10 | Docetaxel | 10 | Resistance to permeation | >240 |
| 11 | Doxorubicin HCl | 2 | Resistance to permeation | >240 |
| 12 | Ellence | 2 | Resistance to permeation | >240 |
| 13 | Etoposide | 20 | Resistance to permeation | >240 |
| 14 | Fludarabine | 25 | Resistance to permeation | >240 |
| 15 | Fluorouracil | 50 | Resistance to permeation | >240 |
| 16 | Gemcitabine | 38 | Resistance to permeation | >240 |
| 17 | Idarubicin | 1 | Resistance to permeation | >240 |
| 18 | Ifosfamide | 50 | Resistance to permeation | >240 |
| 19 | Irinotecan | 20 | Resistance to permeation | >240 |
| 20 | Mechlorethamine | 1 | Resistance to permeation | >240 |
| 21 | Melphalan | 5 | Resistance to permeation | >240 |
| 22 | Methotrexate | 25 | Resistance to permeation | >240 |
| 23 | Mitomycin C | 0.5 | Resistance to permeation | >240 |
| 24 | Mitoxantrone | 2 | Resistance to permeation | >240 |
| 25 | Oxaliplatin | 5 | Resistance to permeation | >240 |
| 26 | Paclitaxel | 6 | Resistance to permeation | >240 |
| 27 | Rituximab | 10 | Resistance to permeation | >240 |
| 28 | Thiotepa | 10 | Resistance to permeation (Note: Explicit caution given due to low permeation time) | 39 |
| 29 | Topotecan | 1 | Resistance to permeation | >240 |
| 30 | Trisenox | 1 | Resistance to permeation | >240 |
| 31 | Vincristine Sulfate | 1 | Resistance to permeation | >240 |
| 32 | Vinorelbine | 10 | Resistance to permeation | >240 |
| 33 | Fentanyl Citrate | 100 mcg/2ml | Resistance to permeation | >240 |
The Study that Proves the Device Meets the Criteria:
The study referenced is the testing performed "as per ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard is a recognized methodology for evaluating the integrity of medical gloves when exposed to hazardous chemicals. The table provided directly presents the results of this testing, showing the breakthrough detection times for each specified drug and Fentanyl Citrate.
Remaining Information Not Present in the Document:
The provided document (an FDA 510(k) clearance letter and Indications for Use statement) does not contain the detailed technical information required to answer the following questions:
- Sample size used for the test set and the data provenance: Not mentioned. The document only presents chemical permeation test results.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical performance test for a glove, not an AI or diagnostic device requiring expert interpretation of results for "ground truth." The "ground truth" here is the direct measurement of chemical breakthrough time.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus building among human readers for diagnostic interpretation, which is not relevant for a glove permeation test.
- 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 for AI-assisted diagnostic devices, not protective equipment like gloves.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is established by the direct measurement of chemical permeation through the glove material according to the ASTM D6978-05 standard. It is a direct physical measurement.
- The sample size for the training set: Not applicable. This refers to the training of machine learning models, which is irrelevant for a glove permeation test.
- How the ground truth for the training set was established: Not applicable. This refers to the training of machine learning models.
§ 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.