(81 days)
The Mediguard Powder-Free Nitrile Examination Glove (tested for use with chemotherapy drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Average BDT |
|---|---|
| 5-Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 1.10 min. |
| Thiotepa | 8.13 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
| Ifosfamide (Ifex) | >240 min. |
| Mitoxantrone | >240 min. |
| Vincristine Sulfate | >240 min. |
| WARNING: Do not use with Carmystine and Thio-Te |
The Mediguard Powder-Free Nitrile Examination Glove (tested for use with chemotherapy drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This document describes the FDA's clearance of the Mediguard Powder-Free Nitrile Examination Glove for medical purposes, including use with certain chemotherapy drugs. This is not a study of an AI/ML device, but rather a regulatory approval for a medical device (examination glove). Therefore, the specific information requested about acceptance criteria and studies related to AI/ML performance, such as sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, do not apply to this document.
However, I can extract the acceptance criteria for the chemotherapy drug breakthrough times and the reported device performance from the provided table.
1. A table of acceptance criteria and the reported device performance
For examination gloves tested for use with chemotherapy drugs, the key performance metric is the "Breakthrough Detection Time (BDT)", which signifies the time it takes for a chemotherapy drug to penetrate the glove material. Although explicit "acceptance criteria" for BDT aren't stated as numerical thresholds in this document, the implicit acceptance standard is that a longer BDT is better, ideally exceeding the typical exposure time during handling. For some drugs, the glove showed exceptional resistance (>240 minutes), while for others (Carmustine, Thiotepa), the resistance was very low, leading to a warning.
| Chemotherapy Drug | Reported Device Performance (Average BDT) | Implicit Acceptance/Performance Standard (Longer is better) |
|---|---|---|
| 5-Fluorouracil | >240 min. | High resistance (exceeded 240-minute test duration) |
| Etoposide (Toposar) | >240 min. | High resistance (exceeded 240-minute test duration) |
| Cyclophosphamide (Cytoxan) | >240 min. | High resistance (exceeded 240-minute test duration) |
| Carmustine | 1.10 min. | Very low resistance (explicit warning issued) |
| Thiotepa | 8.13 min. | Low resistance (explicit warning issued) |
| Paclitaxel (Taxol) | >240 min. | High resistance (exceeded 240-minute test duration) |
| Doxorubicin Hydrochloride | >240 min. | High resistance (exceeded 240-minute test duration) |
| Dacarbazine (DTIC) | >240 min. | High resistance (exceeded 240-minute test duration) |
| Cisplatin | >240 min. | High resistance (exceeded 240-minute test duration) |
| Ifosfamide (Ifex) | >240 min. | High resistance (exceeded 240-minute test duration) |
| Mitoxantrone | >240 min. | High resistance (exceeded 240-minute test duration) |
| Vincristine Sulfate | >240 min. | High resistance (exceeded 240-minute test duration) |
Note: The explicit "WARNING: Do not use with Carmustine and Thio-Tepa" indicates that for these two drugs, the reported breakthrough times (1.10 min and 8.13 min respectively) were considered unacceptable by the manufacturer/FDA for safe use, despite being measured values.
The remaining requested information (2-9) is not applicable or cannot be extracted from this document as it pertains to AI/ML device studies, which this FDA clearance is not.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Matt Clausen Regulatory Affairs Specialist Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060
FEB 2 8 2010
Re: K093726
Trade/Device Name: Mediguard Powder Free Nitrile Examination Glove (Blue) -Tested for use with Chemotherapy Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA Dated: January 26, 2010 Received: January 29, 2010
Dear Mr. Clausen:
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. Clausen
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Susan Tunney
Anthony D. 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): KO93726
Device Name:
Mediguard Powder-Free Nitrile Examination Glove (Blue) - Tested for use with Chemotherapy Drugs
Indications For Use:
The Mediguard Powder-Free Nitrile Examination Glove (tested for use with chemotherapy drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Average BDT |
|---|---|
| 5-Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 1.10 min. |
| Thiotepa | 8.13 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
| Ifosfamide (Ifex) | >240 min. |
| Mitoxantrone | >240 min. |
| Vincristine Sulfate | >240 min. |
WARNING: Do not use with Carmystine and Thio-Te
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093726
Prescription Use (Part 21 CFR 801 Subpart D)
..
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)
9
§ 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.