(97 days)
The PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Cisplatin (1 mg/ml) Cyclophosphamide (20 mg/ml) Dacarbazine (10 mg/ml) Doxorubicin HCI (2 mg/ml) Etoposide (20 mg/ml) Fluorouracil (50 mg/ml) Ifosfamide (50 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCI (2 mg/ml) Paclitaxel (6 mg/ml) Vincrinstine Sulfate (1 mg/ml) Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
ThioTEPA (10 mg/ml), breakthrough detected at 88.6 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 55.2 minutes
Warning: Not for Use With: Carmustine, ThioTEPA
The subject device is a dark blue colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves.
The provided document is a 510(k) summary for medical examination gloves and does not relate to AI/ML powered medical devices. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, sample size for training set, how training set ground truth was established) are not applicable and are not present in this type of submission.
However, I can extract the acceptance criteria and performance data for the device itself (the gloves).
Here's the relevant information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test | Standard(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Chemotherapy Drugs Permeation Resistance | ASTM D6978-05 | No breakthrough for specific drugs up to 240 minutes. | No breakthrough detected up to 240 minutes for: Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Dacarbazine (10 mg/ml), Doxorubicin HCI (2 mg/ml), Etoposide (20 mg/ml), Fluorouracil (50 mg/ml), Ifosfamide (50 mg/ml), Methotrexate (25 mg/ml), Mitomycin C (0.5 mg/ml), Mitoxantrone HCI (2 mg/ml), Paclitaxel (6 mg/ml), Vincristine Sulfate (1 mg/ml), Fentanyl Citrate Injection (100 mcg/2 mL), Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution. |
Breakthrough detected in less than 90 minutes for: ThioTEPA (10 mg/ml) at 88.6 minutes.
Breakthrough detected in less than 60 minutes for: Carmustine (3.3 mg/ml) at 55.2 minutes.
Warning: Do not use with Carmustine or ThioTEPA. |
| Freedom from Pinholes (Leakage) | ASTM D5151-06, ASTM D6319 | 2.5% AQL requirement for leakage. No leakage. | Meets the 2.5% AQL requirement for leakage. Meets the acceptance criteria. |
| Residual Powder | ASTM D6124-06, ASTM D6319 |
§ 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.