(340 days)
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.
Polychloroprene Powder-Free Surgical Glove (White) Tested For Use With Chemotherapy Drugs; Polychloroprene Powder-Free Surgical Glove (Green) Tested For Use With Chemotherapy Drugs
This document is a 510(k) premarket notification for surgical gloves, specifically Polychloroprene Powder-Free Surgical Gloves (White and Green) tested for use with chemotherapy drugs. It is not related to an AI/ML medical device, and therefore does not contain any of the requested information regarding AI/ML study design, such as acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies.
The document primarily focuses on establishing substantial equivalence for the surgical gloves and their performance against chemotherapy drugs. The tables presented show the minimum breakthrough detection time for various chemotherapy drugs when tested with the gloves. This is a performance characteristic of the physical device (gloves), not an AI algorithm.
To explicitly address the numbered points in your request:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: While not explicitly stated as such, the implicit acceptance criteria for these surgical gloves for chemotherapy use would be that they provide a barrier to chemotherapy drugs for a reasonable period. The "minimum breakthrough detection time" is the metric measured.
- Reported Device Performance (Polychloroprene Powder-Free Surgical Glove (White)):
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 - Reported Device Performance (Polychloroprene Powder-Free Surgical Glove (Green)):
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
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided as it's a physical device test, not an AI model.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for a physical device test. The "ground truth" would be the direct measurement of chemical permeation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; this is not an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth here is the measured permeation time of chemotherapy drugs through the glove material, determined through validated laboratory testing methods (likely following ASTM standards for chemical permeation).
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The sample size for the training set: Not applicable; this is not an AI device.
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How the ground truth for the training set was established: Not applicable; this is not an AI device.
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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.
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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
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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) | MinimumBreakthroughDetection 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."
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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) | MinimumBreakthroughDetection 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."
§ 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).