(130 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 and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
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Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Patient Examination Gloves, based on the provided document:
Acceptance Criteria and Reported Device Performance
The device, Powder Free Nitrile Patient Examination Gloves (Blue, White, and Black Colored), was tested for permeation by chemotherapy drugs and Fentanyl Citrate according to ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The acceptance criteria are implied to be the reported "Minimum Breakthrough Detection Time in Minutes" for each drug, which the device performance meets or exceeds.
Device Performance Tables:
1. Blue Colored Gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 10.1 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/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) | 30.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Note: Carmustine (BCNU) has an extremely low permeation time of 10.1 minutes.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
2. White Colored Gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 10.1 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/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) | 10.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Note: Carmustine (BCNU) and Thiotepa have extremely low permeation times: 10.1 minutes and 10.4 minutes, respectively.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
3. Black Colored Gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 14.4 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/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) | 29.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Note: Carmustine (BCNU) and Thiotepa have extremely low permeation times: 14.4 minutes and 29.2 minutes, respectively.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Study Information:
2. Sample size used for the test set and the data provenance:
- The document implies that the "test set" consists of multiple samples of each glove type (Blue, White, Black) that were subjected to testing against the listed chemotherapy drugs and Fentanyl Citrate.
- The exact sample size (number of gloves or individual tests) is not explicitly stated in the provided text.
- The data provenance is not definitively stated, but it is a premarket notification (510(k)) from a Malaysian company (Kossan International Sdn. Bhd.). It is implied that the testing was conducted to support this submission, likely by or for the manufacturer. The data is retrospective in relation to the submission date.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the study involves laboratory testing for chemical permeation, not clinical performance or image interpretation requiring expert opinion. The "ground truth" is established by the direct measurement of chemical breakthrough time following the ASTM D6978-05 standard.
4. Adjudication method for the test set:
- This information is not applicable for a laboratory chemical permeation test. The results are quantitative measurements obtained through instrument analysis.
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:
- This is not applicable as the device is a patient examination glove, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical medical glove and does not involve an algorithm. The testing described is for the barrier properties of the glove material.
7. The type of ground truth used:
- The ground truth is based on direct laboratory measurement of chemical permeation/breakthrough time, as defined by the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
8. The sample size for the training set:
- This is not applicable as the study does not involve an algorithm or machine learning that requires a training set. The data presented is the result of direct physical and chemical property testing.
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device and study.
§ 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.