mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed

• K Number: K190876
• Device Name: mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
• Manufacturer: Mercator Medical (Thailand) LTD.
• Date Cleared: 2019-12-02 ( 242 days)
• Product Code: LZA , LZC
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

mCare® Powder Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05, The following drugs had no breakthrough detected up to 240 minutes

• 1. Cisplatin, 1.0 mg/ml
• 2. Cyclophosphamide (Cytoxan), 20 mg/ml
• 3. Dacarbazine (DTIC), 10.0 mg/ml
• 4. Doxorubicin Hydrochloride, 2.0 mg/ml
• 5. Etoposide (Toposar), 20.0 mg/ml
• 6. Fluorouracil, 50.0 mg/ml
• 7. Methotrexate, 25 mg/ml
• 8. Mitomycin C,0.5 mg/ml
• 9. Paclitaxel (Taxol), 6.0 mg/ml
• 10. Vincristine 1.0 mg/ml

The following drugs showed breakthrough detected in less than 240 minutes:

• 1. Carmustine (BCNU), 3.3 mg/ml: 24.6 minutes

2. Thiotepa (THT) 10.0 mg/ml: 68.9 minutes

Warning-Not for Use with Carmustine and Thiotepa

Device Description

mCare® Powder-Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Mercator Medical (Thailand) LTD regarding their mCare® Powder-Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed.

This document primarily focuses on the regulatory clearance of a physical medical device (examination gloves) and not an AI/ML-driven software device. Therefore, the information required to describe the acceptance criteria and study proving an AI/ML device meets those criteria (questions related to test sets, experts, MRMC studies, ground truth, etc.) is not present in this document.

The document discusses:

• The device's classification and regulation.
• General controls provisions.
• The device's intended use and specific chemotherapy drugs it was tested against for breakthrough time, as per ASTM D6978-05.
• Breakthrough times for tested chemotherapy drugs, explicitly stating that two drugs (Carmustine and Thiotepa) showed breakthrough in less than 240 minutes, leading to a warning.

In summary, this document does not contain the information requested about AI/ML device performance and validation studies.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device validation based on the provided text.

Regulation Number and Section

§ 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.