(255 days)
Not Found
Not Found
No
The device is a medical glove, and the description focuses on its physical properties and resistance to chemotherapy drugs, with no mention of AI or ML.
No.
Gloves are barrier devices that prevent contamination, not therapeutic devices that treat or prevent disease or medical conditions.
No
Explanation: The device is an examination glove, intended to prevent contamination and protect the user from chemotherapy drugs. It does not perform any diagnostic function.
No
The device is a physical examination glove, not a software application. The description clearly indicates it is a "nonsterile disposable device intended for medical purpose that is worn on the examiner's hand".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose, monitor, or screen for diseases or conditions by analyzing things like blood, urine, tissue, etc.
- This device is a glove worn on the hand. Its purpose is to prevent contamination between a patient and an examiner. While it has been tested for use with chemotherapy drugs, this testing relates to the glove's barrier properties, not its ability to analyze a biological specimen.
The description clearly states its intended use is a barrier device worn on the hand for medical purposes. This falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU) is nonsterile 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 list of Chemotherapy Drugs tested (with breakthrough times) is as below:
Carmustine (3.3 mg/ml) | 10.2 minutes
Cisplatin (1.0 mg/ml) | >240 minutes
Cyclophosphamide (20 mg/ml) | >240 minutes
Dacarbazine (10.0 mg/ml) | >240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes
Etoposide (20.0 mg/ml) | >240 minutes
Fluorouracil (50.0 mg/ml) | >240 minutes
Methotrexate (25 mg/ml) | >240 minutes
Mitomycin C (0.5 mg/ml) | >240 minutes
Paclitaxel (6.0 mg/ml) | >240 minutes
Thiotepa (10.0 mg/ml) | 30.2 minutes
Vincristine Sulfate (1.0 mg/ml) | >240 minutes
Please note that Carmustine and Thiotepa have extremely low permeation times of 10.2 minutes.
Product codes
LZA
Device Description
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs -Violet Blue (VBLU)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
Not Found
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
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, layered on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
Hartalega NGC Sdn. Bhd. Ms. Nurul Aisyah Kong Senior Manager-Quality Assurance Dataran SD PJU 9 Bandar Sri Damansara, Kuala Lumpur 52200 MALAYSIA
Re: K151997 Trade/Device Name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs -Violet Blue (VBLU) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 25, 2015 Received: February 22, 2016
Dear Ms. Kong,
This letter corrects our substantially equivalent letter of March 31, 2016.
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. 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.
1
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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151997
Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs -Violet Blue (VBLU)
Indications for Use (Describe)
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU) is nonsterile 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 list of Chemotherapy Drugs tested (with breakthrough times) is as below:
| Carmustine (3.3 mg/ml) | 10.2 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | >240 minutes |
| Cyclophosphamide (20 mg/ml) | >240 minutes |
| Dacarbazine (10.0 mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes |
| Etoposide (20.0 mg/ml) | >240 minutes |
| Fluorouracil (50.0 mg/ml) | >240 minutes |
| Methotrexate (25 mg/ml) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | >240 minutes |
| Paclitaxel (6.0 mg/ml) | >240 minutes |
| Thiotepa (10.0 mg/ml) | 30.2 minutes |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes |
Please note that Carmustine and Thiotepa have extremely low permeation times of 10.2 minutes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."