(221 days)
The Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)-Extended Cuff is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
The Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue (ABLU) is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
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This document is a 510(k) premarket notification decision letter from the FDA for medical gloves. It describes the "Indications for Use" for two types of gloves: "Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)- Extended Cuff" and "Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue (ABLU)".
The acceptance criteria for the devices are based on their resistance to permeation by various chemotherapy drugs, measured by breakthrough time. The study conducted to prove the devices meet these criteria is a chemotherapy drug permeation test.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)- Extended Cuff
| Chemotherapy Drug (Concentration) | Acceptance Criteria (Breakthrough Time) | Reported Device Performance |
|---|---|---|
| Carmustine (3.3 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | 20.3 minutes |
| Cisplatin (1.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Cyclophosphamide (20 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Dacarbazine (10.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Doxorubicin HCl (2.0mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Etoposide (20.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Methotrexate (25 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Paclitaxel (6.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Thiotepa (10.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | 100.6 minutes |
| Vincristine Sulfate (1.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
Device: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue (ABLU)
| Chemotherapy Drug (Concentration) | Acceptance Criteria (Breakthrough Time) | Reported Device Performance |
|---|---|---|
| Carmustine (3.3 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | 43.8 minutes |
| Cisplatin (1.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Cyclophosphamide (20 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Dacarbazine (10.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Doxorubicin HCl (2.0mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Etoposide (20.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Methotrexate (25 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Paclitaxel (6.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Thiotepa (10.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | 97.8 minutes |
| Vincristine Sulfate (1.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
Note: The document states "Please note that Carmustine and Thiotepa have extremely low permeation times of 20.3 minutes and 100.6 minutes" for VBLU gloves, and "Please note that Carmustine and Thiotepa have extremely low permeation times of 43.8 minutes" for ABLU gloves. This implies that while these times are lower than other drugs, they are considered acceptable for appropriate use with awareness of the breakthrough time.
The provided document does not contain the following information typically associated with AI/software medical device studies:
- 2. Sample size used for the test set and the data provenance (This is a physical product test, not an AI model test.)
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable to a physical product permeation test.)
- 4. Adjudication method (Not applicable.)
- 5. Multi-reader multi-case (MRMC) comparative effectiveness study (Not applicable, as this is not an AI diagnostic device.)
- 6. Standalone (algorithm only without human-in-the-loop performance) study (Not applicable, as this is not an AI algorithm.)
- 7. The type of ground truth used (For this type of device, the "ground truth" is the empirically measured breakthrough time of the chemical through the glove material under controlled laboratory conditions, typically following standards like ASTM D6978. The document does not specify the exact standard or methodology, but it's an objective measurement.)
- 8. The sample size for the training set (Not applicable, as this is not an AI model.)
- 9. 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.