(340 days)
Not Found
Not Found
No
The summary describes a surgical glove and its performance against chemotherapy drugs, with no mention of AI or ML.
No
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.
No
Explanation: The device is a surgical glove, which is a barrier protection device used during surgery to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical surgical glove made of polychloroprene, not a software application.
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 by being worn by operating room personnel. This is a barrier function, not a diagnostic one.
- Device Description: The device is a surgical glove, which is a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a patient's health status.
- Performance Studies: The performance studies focus on the glove's barrier properties against chemotherapy drugs, not on diagnostic accuracy or metrics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC
Device Description
Polychloroprene Powder-Free Surgical Glove (White) Tested For Use With Chemotherapy Drugs; Polychloroprene Powder-Free Surgical Glove (Green) 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 room 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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).
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 stylized graphic of three human profiles facing right, stacked on top of each other, with flowing lines connecting them. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2015
PT Medisafe Technologies Anil Taneja CEO J1. Batang Kuis Gg. Tambak Rejo/ Pasar IX Desa Buntu Bedimbar, Tanjung Morawa Medan, North Sumatra 20362 Indonesia
Re: K142190
Trade/Device
Trade/Device Name: Polychloroprene Powder-Free Surgical Glove (White) Tested For Use With Chemotherapy Drugs; Polychloroprene Powder-Free Surgical Glove (Green) Tested For Use With Chemotherapy Drugs
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO, LZC Dated: June 16, 2015 Received: June 19, 2015
Dear Mr. Taneja:
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 - Anil Taneja
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 I. Keith, M.S. Division 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) K142190
Device Name
Polychloroprene Powder-Free Surgical Glove (White) Tested for Use with Chemotherapy Drugs.
Indications for Use (Describe)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
| Test Chemotherapy Drug | Concentration
(mg/ml) | Minimum
Breakthrough
Detection Time
(minutes) |
|---------------------------|--------------------------|--------------------------------------------------------|
| Carmustine | 3.3 mg/ml | 31.1 |
| Cisplatin | 1.0 mg/ml | > 240 min |
| Cyclophosphamide | 20.0 mg/ml | > 240 min |
| Dacarbazine | 10.0 mg/ml | > 240 min |
| Doxorubicin Hydrochloride | 2.0 mg/ml | > 240 min |
| Etoposide | 20.0 mg/ml | > 240 min |
| Fluorouracil | 50.0 mg/ml | > 240 min |
| Ifosfamide | 50.0 mg/ml | > 240 min |
| Mechloroethamine HCl | 1.0 mg/ml | > 240 min |
| Melphalan | 5.0 mg/ml | > 240 min |
| Methotrexate | 25.0 mg/ml | > 240 min |
| Paclitaxel | 6.0 mg/ml | > 240 min |
| Thiotepa | 10.0 mg/ml | 30.4 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 min |
Please note that the following drugs have extremely low permeation times:
-
- Carmustine (3.3 mg/ml) : 31.1 minutes.
-
- Thiotepa (10.0 mg/ml) : 30.4 minutes.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
2 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BECOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM IO 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) Staffl 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."
3
Indications for Use
510(k) Number (if known) K142190
Device Name
Polychloroprene Powder-Free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs.
Indications for Use (Describe)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
| Test Chemotherapy Drug | Concentration
(mg/ml) | Minimum
Breakthrough
Detection Time
(minutes) |
|---------------------------|--------------------------|--------------------------------------------------------|
| Carmustine | 3.3mg/ml | 0.20 |
| Cisplatin | 1.0mg/ml | > 240 min |
| Cyclophosphamide | 20.0 mg/ml | > 240 min |
| Dacarbazine | 10.0 mg/ml | > 240 min |
| Doxorubicin Hydrochloride | 2.0mg/ml | > 240 min |
| Etoposide | 20.0 mg/ml | > 240 min |
| Fluorouracil | 50.0 mg/ml | > 240 min |
| Ifosfamide | 50.0 mg/ml | > 240 min |
| Mechlorethamine HCl | 1.0mg/ml | > 240 min |
| Melphalan | 5.0mg/ml | > 240 min |
| Methotrexate | 25.0 mg/ml | > 240 min |
| Paclitaxel | 6.0mg/ml | > 240 min |
| Thiotepa | 10.0 mg/ml | 15.4 |
| Vincristine Sulfate | 1.0mg/ml | > 240 min |
Please note that the following drugs have extremely low permeation times:
-
- Carmustine (3.3 mg/ml) : 0.20 minutes.
-
- Thiotepa (10.0 mg/ml) : 15.4 minutes.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
2 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BECOW THIS LINE - CONTINUE ON A SEPARATE PAGE IE NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED EORM IO 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) Staffl 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."