POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Device Facts
| Record ID | K122999 |
|---|---|
| Device Name | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
| Applicant | Top Glove Sdn. Bhd. |
| Product Code | LZA · General Hospital |
| Decision Date | Nov 30, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. in addition, these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
Device Story
Blue Powder Free Nitrile Examination Gloves are disposable, patient examination gloves. Worn by healthcare professionals to provide a barrier against contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings; provides protection during handling of hazardous chemotherapy agents. Benefits include reduced risk of cross-contamination and chemical exposure to the examiner.
Clinical Evidence
No clinical data. Bench testing only, specifically permeation testing per ASTM D6978-05 for chemotherapy drugs.
Technological Characteristics
Nitrile examination glove; powder-free. Tested for chemotherapy drug permeation per ASTM D6978-05. Class I medical device.
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner, including use during handling of chemotherapy drugs.
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.
Related Devices
- K071072 — SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE · Shanghai China Star Corp · Aug 30, 2007
- K102623 — BLUE POWDERFREE NITRILE EXAMINATION GLOVE · Pt. Medisafe Technologies · Jun 6, 2011
- K141623 — EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM · Eco Medi Glove Sdn. Bhd. · Oct 7, 2014
- K211390 — Nitrile Blue Powder-free Examination Glove · Cardinal Health200, LLC · Aug 28, 2021
- K170136 — Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs · Shandong Feiyang Professional Gloves Co., Ltd. · Aug 25, 2017
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
## November 30, 2012
Mr. Eddy Rosyadie Quality Assurance Manager Top Glove Sdn. Bhd Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru Klang, Selangor Darul Ehsan Malaysia 41050
Re: K122999
Trade/Device Name: Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: October 19, 2012 Received: October 22, 2012
Dear Mr. Rosyadie:
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 Eederal Register.
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## Page 2 - Mr. Rosyadie
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.goy/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,
Anthony De mita
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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## INDICATIONS FOR USE
510 (k) Number (if known) : K12299999
Blue Powder Free Nitrile Examination Gloves Device Name : Tested For Use With Chemotherapy Drugs
Indication For Use :
Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
in addition, these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time in<br>Minutes, 0.01 ug/cm2/minute |
|---|--------------------------------------------------|-----------------------------------------------------------------------|
| 1 | Cisplatin, 1.0 mg/ml (1,000ppm) | >240 |
| 2 | Cyclophosphamide (Cytoxan),20.0mg/ml (20,000ppm) | >240 |
| 3 | Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) | >240 |
| 4 | Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 |
| 5 | Etoposide (Toposar), 20.0 mg/ml (20,000)ppm | >240 |
| 6 | Fluorouracil, 50.0 mg/ml (50,000ppm) | >240 |
| 7 | Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) | >240 |
| 8 | Carmustine (BCNU)3.3mg/ml(3,300ppm) | 0.9 |
| 9 | Thiotepa, 10.0mg/ml (10,000ppm) | 0.05 |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes
> Carmustine (BCNU)3.3mg/ml(3,300ppm) Thiotepa, 10.0mg/ml ( 10,000ppm)
Prescription Use (part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use X ( 21 CFR 801 Subpart C )
( PLEASE DO NOT WRITE THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
> Digitally signed by Maria Cruz-fisher Maria Cruz-fisher Mercede Colored Colored Colorenter Cou-HDS, Govenment, ou=HDS, oreFDA,
> Maria Cruz-fisher Cruzer, over consideracions constitution of FDA,
> Maria Cruz-fish C 0.9.2342.19200300.100.1.1=2000576169 Date: 20
(Division Sign-Off) (Division Sign~on)
Division of Anesthesiology, General Hospital Division of Ancol, Dental Devices
510(k) Number:
