(112 days)
Not Found
Not Found
No
The summary describes a surgical glove and its testing for chemotherapy drug permeation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device, a surgeon's glove, is intended to protect a surgical wound from contamination, which is a preventative rather than a therapeutic function.
No
The device is described as a "powder free surgeon's glove" intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device description clearly states it is a "powder free surgeon's glove," which is a physical, hardware device made of synthetic rubber.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination and for use with chemotherapy drugs. This is a barrier function and protection for the user and patient, not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Device Description: The description confirms it's a surgeon's glove made of synthetic rubber, designed for protection.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the glove's barrier properties against chemotherapy drugs, which is relevant to its protective function, not diagnostic accuracy.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment decisions. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
This powder free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating, nom personnel to protect a surgical wound from contamination.
In addition, these gloves were tested for use with Chemotherapy Drugs in accordance ASTM D6978-05 (2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes
KGO, LZC
Device Description
Sterile Polyiosprene Surgical Powder Free Glove 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating, nom personnel
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 Drugs Permeation (Breakthrough Detection Time) in Minutes
The following chemicals have been tested with these gloves.
| Chemotherapy Drugs | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3mg/ml | 13.0 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | >240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | >240 |
| Etoposide (Toposar) | 20.0mg/ml | >240 |
| Fluorouracil | 50.0mg/ml | >240 |
| Methotrexate | 25.0mg/ml | >240 |
| Paclitaxel | 6.0mg/ml | >240 |
| Thiotepa | 10.0mg/ml | 24.9 |
| Vincristine Sulfate | 1.0mg/ml | >240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU): 13.0 minutes and Thiotepa: 24.9
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
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Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2017
TG Medical SDN. BHD. Fatima Mohamad OA. Assistant Manager Lot 5091. Jalan Teratai Batu 5, Off Jalan Meru Klang, 41050 My
Re: K171276
Trade/Device Name: Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460
Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: July 24, 2017 Received: July 28, 2017
Dear Fatima Mohamad:
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.
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
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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 (DICE) 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 (DICE) 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,
Tara A. Ryan -S 2017.08.21 17:25:27 -04'00
for
Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K171276
Device Name
Sterile Polyiosprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
This powder free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating, nom personnel to protect a surgical wound from contamination.
In addition, these gloves were tested for use with Chemotherapy Drugs in accordance ASTM D6978-05 (2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drugs Permeation
(Breakthrough Detection Time) in Minutes
The following chemicals have been tested with these gloves.
| Chemotherapy Drugs | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3mg/ml | 13.0 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | >240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | >240 |
| Etoposide (Toposar) | 20.0mg/ml | >240 |
| Fluorouracil | 50.0mg/ml | >240 |
| Methotrexate | 25.0mg/ml | >240 |
| Paclitaxel | 6.0mg/ml | >240 |
| Thiotepa | 10.0mg/ml | 24.9 |
| Vincristine Sulfate | 1.0mg/ml | >240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU): 13.0 minutes and Thiotepa: 24.9
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 804 Subpart D)
[X] Over-The-Counter Use (21 GFR 801 Subpart C)
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FORM FDA 3881 (8/14)
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