(95 days)
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Not Found
No
The 510(k) summary describes a standard medical glove and does not mention any AI or ML components or functionalities.
No.
The intended use states that the glove is "worn on the examiner's hand to prevent contamination between patient and examiner," indicating a preventative or barrier function rather than directly treating a disease or condition.
No
Explanation: The device, a glove, is intended to prevent contamination between patient and examiner, primarily for protection. It does not gather information from the body or its functions to make a diagnosis.
No
The device is a physical glove, not software. The description clearly indicates it is a "disposable device intended for medical purposes that is worn on the examiner's hand".
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 test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The description is for examination gloves, which are physical barriers.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the barrier properties against chemotherapy drugs, which is relevant to the glove's function as a protective barrier, not a diagnostic test.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This glove does not perform any such 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.
Product codes
LYY, LZC
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
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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
Chemotherapy Drug Permeation (Average Breakthrough Detection Time in Minutes)
Thiotepa (10.0 mg / ml): 7.71
Carmustine (BCNU) (3.3 mg / ml): 63.03
Dacarbazine (DTIC) (10.0 mg / ml): > 240
Cyclophosphamide (Cytoxan) (20.0 mg / ml): > 240
Doxorubicin Hydrochloride (2.0 mg / ml): > 240
Fluorouracil (50.0 mg / ml): > 240
Cisplatin (1.0 mg / ml): > 240
Etoposide (Toposar) (20.0 mg / ml): > 240
Paclitaxel (Taxol) (6.0 mg / ml): > 240
Ifosfamide (50.0 mg / ml): > 240
Methotrexate (25.0 mg / ml): > 240
Mitomycin C (0.5 mg / ml): > 240
Mitoxantrone (2.0 mg / ml): > 240
Vincristine Sulfate (1.0 mg / ml): > 240
Please note that Thiotepa has an extremely low permeation time of less than 30 minutes
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black. The seal is simple and iconic, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Cho Sow Fong Quality Assurance Manager GX Corporation Sdn Bhd Lot 6487A, Batu 5 3/4, Sementa, Jalan Kapar 42100 Klang, Selangor Darul Ehsan MALAYSIA
OCT 4 2010
Re: K101828
Trade/Device Name: Powder Free Latex Examination Gloves, Tested For Use with Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY, LZC Dated: September 3, 2010 Received: September 7, 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
hr for
Anthony 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
K101 828
Indications for Use
510(k) Number (if known): K101828
Device Name:
Powder Free Latex Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue).
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.
Chemotherapy Drug Permeation (Average Breakthrough Detection Time in Minutes)
| Thiotepa (10.0 mg / ml) | 7.71 |
|---|---|
| Carmustine (BCNU) (3.3 mg / ml) | 63.03 |
| Dacarbazine (DTIC) (10.0 mg / ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg / ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg / ml) | > 240 |
| Fluorouracil (50.0 mg / ml) | > 240 |
| Cisplatin (1.0 mg / ml) | > 240 |
| Etoposide (Toposar) (20.0 mg / ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg / ml) | > 240 |
| Ifosfamide (50.0 mg / ml) | > 240 |
| Methotrexate (25.0 mg / ml) | > 240 |
| Mitomycin C (0.5 mg / ml) | > 240 |
| Mitoxantrone (2.0 mg / ml) | > 240 |
| Vincristine Sulfate (1.0 mg / ml) | > 240 |
Please note that Thiotepa has an extremely low permeation time of less than 30 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)
Elizabeth P. Clance-Wills
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
101828 510(k) Number:
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