(242 days)
Not Found
Not Found
No
The device is a physical examination glove and the description focuses on its material properties and resistance to chemotherapy drugs, with no mention of AI or ML.
No
The device, examination gloves, is intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a disease or condition.
No
Explanation: The device is described as "disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner." This indicates it is a protective barrier, not a diagnostic tool used to identify or determine the nature of a disease or condition.
No
The device is a physical product (gloves) and the description focuses on their material properties and performance against chemotherapy drugs, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection during medical procedures.
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Lack of IVD Characteristics: The description does not mention any interaction with human specimens for diagnostic purposes. The testing performed relates to the glove's barrier properties against chemotherapy drugs, which is a performance characteristic of the device itself, not a diagnostic test on a patient sample.
Therefore, the mCare® Powder Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed are medical devices, but they do not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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
-
- Cisplatin, 1.0 mg/ml
-
- Cyclophosphamide (Cytoxan), 20 mg/ml
-
- Dacarbazine (DTIC), 10.0 mg/ml
-
- Doxorubicin Hydrochloride, 2.0 mg/ml
-
- Etoposide (Toposar), 20.0 mg/ml
-
- Fluorouracil, 50.0 mg/ml
-
- Methotrexate, 25 mg/ml
-
- Mitomycin C,0.5 mg/ml
-
- Paclitaxel (Taxol), 6.0 mg/ml
-
- Vincristine 1.0 mg/ml
The following drugs showed breakthrough detected in less than 240 minutes:
-
- Carmustine (BCNU), 3.3 mg/ml: 24.6 minutes
- Thiotepa (THT) 10.0 mg/ml: 68.9 minutes
Warning-Not for Use with Carmustine and Thiotepa
Product codes
LZA, LZC
Device Description
mCare® Powder-Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested for use with chemotherapy drugs per ASTM D6978-05.
Key results:
- No breakthrough detected up to 240 minutes for: Cisplatin, Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), Fluorouracil, Methotrexate, Mitomycin C, Paclitaxel (Taxol), Vincristine
- Breakthrough detected in less than 240 minutes for: Carmustine (BCNU) (24.6 minutes), Thiotepa (THT) (68.9 minutes)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are displayed side-by-side.
Mercator Medical (Thailand) LTD % Kevin Walls Principal Consultant Regulatory Insight, Inc. Contact Address
Re: K190876
Trade/Device Name: mCare® Powder-Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: October 26, 2019 Received: October 28, 2019
Dear Kevin Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K190876
Device Name
mCare® Powder-Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
Indications for Use (Describe)
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
-
- Cisplatin, 1.0 mg/ml
-
- Cyclophosphamide (Cytoxan), 20 mg/ml
-
- Dacarbazine (DTIC), 10.0 mg/ml
-
- Doxorubicin Hydrochloride, 2.0 mg/ml
-
- Etoposide (Toposar), 20.0 mg/ml
-
- Fluorouracil, 50.0 mg/ml
-
- Methotrexate, 25 mg/ml
-
- Mitomycin C,0.5 mg/ml
-
- Paclitaxel (Taxol), 6.0 mg/ml
-
- Vincristine 1.0 mg/ml
The following drugs showed breakthrough detected in less than 240 minutes:
-
- Carmustine (BCNU), 3.3 mg/ml: 24.6 minutes
- Thiotepa (THT) 10.0 mg/ml: 68.9 minutes
Warning-Not for Use with Carmustine and Thiotepa
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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