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The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-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 87.6 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 34.3 minutes
Warning: Not for Use With: Carmustine, ThioTEPA

The subject device is a green colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves.

This document, K220541, is a 510(k) Premarket Notification from the FDA regarding "PureZero LIMON Nitrile Powder-Free Exam Gloves" and "PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves." It focuses on the substantial equivalence of these gloves to a predicate device and their resistance to permeation by various substances.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document describes the testing performed for medical gloves to demonstrate their chemical resistance and physical properties, rather than an AI/ML powered medical device. Therefore, questions 2, 3, 4, 5, 8, and 9, which apply specifically to AI/ML device studies (test set sample size, data provenance, expert adjudication, MRMC studies, training set details), are not directly applicable to this document's content.

1. Table of Acceptance Criteria and Reported Device Performance

The document presents several key performance metrics for the gloves, tested against specific ASTM and ISO standards.

For "breakthrough detected in less than 90 minutes": ThioTEPA (10 mg/ml), Carmustine (3.3 mg/ml). (Note: Specific breakthrough times would be the acceptance criteria for these, implied to be under 90 minutes, with a warning not to use for these specific chemicals). | PureZero LIMON / LIMON-XTRA Gloves:
• 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), Vincrinstine 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 87.6 minutes, Carmustine (3.3 mg/ml) at 34.3 minutes.
• Warning: Not for Use With: Carmustine or ThioTEPA. |
| Detection of Holes (Leakage) | ASTM D5151-06, ASTM D6319 | 2.5% AQL (Acceptable Quality Level) (or implied to meet this general glove standard), No leakage. | Testing shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. |
| Residual Powder | ASTM D6124-06, ASTM D6319 |

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