(99 days)
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Not Found
No
The summary describes a physical medical glove and its performance against chemotherapy drugs, with no mention of software, algorithms, or AI/ML concepts.
No
The device, a disposable glove, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
This device is a glove intended to prevent contamination between the patient and the examiner and has been tested for use with chemotherapy drugs to assess permeation, not to diagnose medical conditions.
No
The device is a physical glove, not software. The description clearly states it is a "Powder Free Nitrile Examination Gloves".
No, 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 examiner's hand. This is a barrier device for personal protection and infection control.
- Device Description: It's described as a "Powder Free Nitrile Examination Glove". This is a physical barrier.
- No mention of in vitro testing: The description and performance studies focus on the glove's ability to resist permeation by chemotherapy drugs. This is a test of the glove's physical properties and barrier function, not a test performed in vitro on biological samples to diagnose or monitor a medical condition.
IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or treatment. This glove does not perform such a function.
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 (comma separated list FDA assigned to the subject device)
LZA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
examiner's hand
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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) 3.48
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) 2.97
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 Results: Carmustine and Thio-Tepa have extremely low permeation time of 3.48 and 2.97 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
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§ 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling waves or stylized human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Cho S. Fong Quality Assurance/ Regulatory Affairs Manager GX Corporation SDN BHD Lot 6487A, Batu 53/4, Sementa, Jalan Kapar Klang, Selangdor Darul Ehsan, Malaysia 42100
NOV - 2 2010
Re: K102074
Trade/Device Name: Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, Blue (SG) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 29, 2010 Received: October 4, 2010 .
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. 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
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 (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 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/ResourcesforYou/Industry/default.htm.
· Sincerely vours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, 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): | K102074 | NOV - 2 2010 |
|---|---|---|
| Device Name: | Powder Free Nitrile Examination Gloves, | |
| Tested For Use With Chemotherapy Drugs, Blue (SG). |
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) | > 240 |
|---|---|
| Mitomycin C (5.0 mg/mL) | > 240 |
| Carmustine (BCNU) (3.3 mg/mL) | 3.48 |
| 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) | 2.97 |
| 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 |
Please note that the following drugs; Carmustine and Thio-Tepa have extremely low
permeation time of 3.48 and 2.97 minutes.
| Prescription Use _______
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use _______ X
(21 CFR 801 Subpart C) |
| --------------------------------------------------------- | -------- | ---------------------------------------------------------- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
h
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Clivision of Anesthesiology, General Devices Division of Anesthoolors of Infection Control, Devices
510(k) Number: K102074 Page 1 of