(232 days)
A powder free nitrile 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.
The tested chemotherapy drugs and their breakthrough detection time are as follows :
| Chemotherapy Drugs & concentration | Average Breakthrough Detection Time |
|---|---|
| Carmustine (BCNU), 3300ppm | 60.2 |
| Cisplatin, 1000ppm | > 240 min |
| Cyclophosphamide (Cytoxan), 20,000 ppm | > 240 min |
| Dacarbazine (DTIC), 10,000 ppm | > 240 min |
| Doxorubicin Hydrochloride, 2000 ppm | > 240 min |
| Etoposide (Toposar), 20,000 ppm | > 240 min |
| Fluorouracil, 50,000 ppm | > 240 min |
| Ifosfamide, 50,000 ppm | > 240 min |
| Methotrexate, 25,000 ppm | > 240 min |
| Mitomycin C, 500 ppm | > 240 min |
| Mitoxantrone, 2000 ppm | > 240 min |
| Paclitaxel (Taxol), 6000 ppm | > 240 min |
| Thiothepa, 10,000 ppm | 105.6 |
| Vincristine Sulfate, 1000 ppm | > 240 min |
Please note that the following drugs have low permeation times: Carmustine - 60.2 minutes Thiothepa - 105.6 minutes
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Blue Nitrile Examination Gloves Tested With Chemotherapy Drugs". It primarily focuses on the regulatory approval process and includes a table of chemotherapy drug breakthrough times. This document does not describe the acceptance criteria of a device nor a study that proves the device meets those criteria in the context of an AI/medical imaging or diagnostic device.
The information requested in the prompt (sample size for test/training sets, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, etc.) is relevant for the evaluation of AI/diagnostic devices, not for examination gloves.
Therefore,Based on the provided document, the requested information about acceptance criteria and a study proving a device meets those criteria cannot be extracted. The document is a 510(k) premarket notification for "Powder Free Blue Nitrile Examination Gloves Tested With Chemotherapy Drugs" and pertains to regulatory clearance, not a study evaluating an AI/diagnostic device against specific performance acceptance criteria.
The only "performance" reported is related to the breakthrough detection time of chemotherapy drugs through the glove, which is a chemical resistance test, not a measure of diagnostic accuracy or AI performance.
Therefore, I cannot populate the table or answer the specific questions as they relate to a different type of device evaluation (e.g., AI in medical imaging) than what is presented in the document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2013
Mr. Patrick Leong Chief Operation Officer Tekmedic (M) Sdn Bhd Plot 4, Tanjung Kling Industrial Area Tanjung Bruas Jetty, Tanjung Kling Malacca, Malaysia 76400
Re: K121592
Trade/Device Name: Powder Free Blue Nitrile Examination Gloves Tested With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: December 20, 2012 Received: December 26, 2012
Dear Mr. Leong:
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 - Mr. Leong
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,
Anthon Lo m
Anthony D. Watson, B.S., M.S., M.B.A. 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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4.0 Indication For Use Statement
K121592 510 (K) Number (if known) :
,
Powder Free Blue Nitrile Examination Glove Tested With Device Name : Chemotherapy Drugs
Indication For Use
A powder free nitrile 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.
The tested chemotherapy drugs and their breakthrough detection time are as follows :
| Chemotherapy Drugs & concentration | Average Breakthrough Detection Time |
|---|---|
| Carmustine (BCNU), 3300ppm | 60.2 |
| Cisplatin, 1000ppm | > 240 min |
| Cyclophosphamide (Cytoxan), 20,000 ppm | > 240 min |
| Dacarbazine (DTIC), 10,000 ppm | > 240 min |
| Doxorubicin Hydrochloride, 2000 ppm | > 240 min |
| Etoposide (Toposar), 20,000 ppm | > 240 min |
| Fluorouracil, 50,000 ppm | > 240 min |
| Ifosfamide, 50,000 ppm | > 240 min |
| Methotrexate, 25,000 ppm | > 240 min |
| Mitomycin C, 500 ppm | > 240 min |
| Mitoxantrone, 2000 ppm | > 240 min |
| Paclitaxel (Taxol), 6000 ppm | > 240 min |
| Thiothepa, 10,000 ppm | 105.6 |
| Vincristine Sulfate, 1000 ppm | > 240 min |
Please note that the following drugs have low permeation times: Carmustine - 60.2 minutes Thiothepa - 105.6 minutes
Prescription Use Part 21 CFR 801 Subpart D Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Claverie 2013.01.16 17:41:05 -05'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.