K090568 · Medline Industries, Inc. · LZA · Oct 2, 2009 · General Hospital
Device Facts
Record ID
K090568
Device Name
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
Applicant
Medline Industries, Inc.
Product Code
LZA · General Hospital
Decision Date
Oct 2, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.6250
Device Class
Class 1
Indications for Use
The Medline Powder-Free Nitrile Examination Glove with Aloe (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.
Device Story
Disposable nitrile examination glove with aloe coating; worn on examiner's hand to provide barrier protection against contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs. Used in clinical settings by healthcare professionals. Provides barrier protection; alerts user to specific drug breakthrough times. Warning provided against use with Carmustine and Thio-Tepa due to breakthrough times.
Clinical Evidence
Bench testing only. Permeation testing performed for 12 chemotherapy drugs (5-Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thiotepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin, Ifosfamide, Mitoxantrone, Vincristine Sulfate) to determine breakthrough detection times.
Technological Characteristics
Material: Nitrile rubber with aloe coating. Form factor: Disposable examination glove. Energy source: None. Sterilization: Not specified. Connectivity: None. Software: None.
Indications for Use
Indicated for use as a disposable patient examination glove to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs. Contraindicated for use with Carmustine and Thio-Tepa.
Regulatory Classification
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.
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Mr. Matt Clausen Regulatory Affairs Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060
## OCT - 2 2009
Re: K090568
Trade/Device Name: Medline Powder-Free Nitrile Examination Glove with Aloe (Green) - Tested for use with Chemotherapy Drugs
Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC, LZA Dated: September 22, 2009 Received: September 23, 2009
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.
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. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Susan Runner
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K090568
Device Name:
Medline Powder-Free Nitrile Examination Glove with Aloe (Green) – Tested for use with Chemotherapy Drugs
Indications For Use:
The Medline Powder-Free Nitrile Examination Glove with Aloe (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 | 19.31 min. |
| Thiotepa | 26.88 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 Carmustine and Thio-Tepa.
Sheila A. Murphy, M.D.
ैं.
मुंबई को बाद में बाद में बाद में बाद में बाद में बाद में बाद में में में में में में में में में में में में में में में में में में में में में में में में में में में
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090568
Prescription Use (Part 21 CFR 801 Subpart D)
(
Over-the-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
