(189 days)
Not Found
Not Found
No
The summary describes a standard medical glove and does not mention any AI or ML capabilities.
No
The device is a glove intended to prevent contamination between patient and examiner, and is tested for use with chemotherapy drugs, indicating it modifies the care setting through barrier protection, not by directly treating a medical condition.
No
Explanation: The device is described as a "glove" intended "to prevent contamination between patient and examiner." Its performance is measured by "Chemotherapy Drug Permeation (Breakthrough Detection Time in Minutes)," which indicates its barrier function, not its ability to diagnose a condition. There is no mention of it collecting data about a patient's health or disease.
No
The device is a physical glove, not software. The description clearly states it is a "Sterile, Powder Free Nitrile Examination Glove".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: It's described as a glove, a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on chemotherapy drug permeation, which relates to the barrier function and safety for the user, not diagnostic accuracy.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Product codes
LZA, LZC
Device Description
Sterile, Powder Free Nitrile Examination Gloves, Blue Tested For Use With Chemotherapy Drugs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand
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)
Chemotherapy Drug Permeation (Breakthrough Detection Time in Minutes)
Dacarbazine (DTIC) (10.0 mg/mL): > 240
Mitomycin C (5.0 mg/mL): > 240
Carmustine (BCNU) (3.3 mg/mL): 3.57
Cyclophosphamide (Cytoxan) (20.0 mg/mL): > 240
Doxorubicin Hydrochloride (2.0 mg/mL): > 240
5-Fluorouracil (50.0 mg/mL): > 240
Cisplatin (1.0 mg/mL): > 240
Etoposide (20.0 mg/mL): > 240
Paclitaxel (taxol) (6.0 mg/mL): > 240
Thio-Tepa (10.0 mg/mL): 24.39
Vincristine Sulfate (50.0 mg/mL): > 240
Methotrexate (25.0 mg/mL): > 240
Mitoxantrone (100.0 mg/mL): > 240
Ifosfamide (Ifex) (50.0 mg/mL): > 240
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Breakthrough Detection Time in Minutes for various chemotherapy drugs.
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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. In the center is a stylized caduceus symbol, which is often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Mr. Cho Sow Fong Quality Assurance Manager GX Corporation SDN BHD Lot 6491-A, Batu 5%, Sementa, Off Jalan Kapar, 42100 Klang Selangor Darul Ehsan MALAYSIA
DEC 2 8 2009
Re: K091851
Trade/Device Name: Sterile, Powder Free Nitrile Examination Gloves, Blue Tested for with Chemotherapy Drugs Regulation Number: 880.6250 Regulation Name: Patient Examination Glove ... Regulatory Class: 1 Product Code: LZA, LZC Dated: December 15, 2009 Received: December 17, 2009
Dear Mr. Fong:
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.
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
Page 2- Mr. Fong
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony O. Rutan
Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K091851
Device Name: Sterile, Powder Free Nitrile Examination Gloves, Blue Tested For Use With Chemotherapy Drugs.
Indication For Use:
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Breakthrough Detection Time in Minutes)
| Dacarbazine (DTIC) (10.0 mg/mL) |
|---|
| Mitomycin C (5.0 mg/mL) |
| Carmustine (BCNU) (3.3 mg/mL) |
| Cyclophosphamide (Cytoxan) (20.0 mg/mL) |
| Doxorubicin Hydrochloride (2.0 mg/mL) |
| 5-Fluorouracil (50.0 mg/mL) |
| Cisplatin (1.0 mg/mL) |
| Etoposide (20.0 mg/mL) |
| Paclitaxel (taxol) (6.0 mg/mL) |
| Thio-Tepa (10.0 mg/mL) |
| Vincristine Sulfate (50.0 mg/mL) |
| Methotrexate (25.0 mg/mL) |
| Mitoxantrone (100.0 mg/mL) |
| Ifosfamide (Ifex) (50.0 mg/mL) |
Warning: Do Not Use with Thiotepa and Carmustine
- Prescription Use -(Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 801 Subpart C)
240 > 240 3.57 > 240 > 240 > 240 > 240 > 240 > 240 24.39 > 240 > 240 > 240 > 240
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE (F NEEDED)
AND/OR
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Elizabet P. Clauss-Will
(Division Sign-Off) (Division of Anesthesiology, General Heapital Infection Control, Dental Devices
Page 1 of
510(k) Number: K09183