POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS

K113100 · Maxter Glove Manufacturing Sdn Bhd · LZA · Feb 6, 2012 · General Hospital

Device Facts

• Record ID: K113100
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
• Applicant: Maxter Glove Manufacturing Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Feb 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder free 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Blue powder-free nitrile examination gloves; disposable; non-sterile. Worn by healthcare professionals during patient examinations to provide a protective barrier against contamination. Tested for permeation resistance against specific chemotherapy drugs (e.g., Cisplatin, Cyclophosphamide, Doxorubicin) per ASTM D6978-05. Provides physical barrier protection; does not involve electronic inputs, algorithms, or software.

Clinical Evidence

Bench testing only. Testing performed in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Breakthrough detection times reported for nine chemotherapy agents.

Technological Characteristics

Nitrile rubber material; powder-free; non-sterile; disposable. Form factor: examination glove. Testing performed per ASTM D6978-05 for chemotherapy drug permeation.

Indications for Use

Indicated for use as a disposable patient examination glove worn by medical examiners to prevent cross-contamination between patient and examiner. Tested for use with specific 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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Yap P. Geeh Assistant Technical Sales Manager MAXTER GLOVE MANUFACTURING SDN BHD Lot 6070. Jalan Haji Abdul Manan 610 Miles Off Jalan Meru Klang, Selangor MALAYSIA 41050

FEB - 6 2012

Re: K113100

Trade/Device Name: Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: January 16, 2012 Received: January 19, 2012

Dear Mr. Geeh:

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. Geeh

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

\$\\$\$ fa Anthony D. lvatson

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

Enclosure

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Image /page/2/Picture/0 description: The image shows a logo for MAXTER GLOVE MANUFACTURING SDN. BHD. The logo features a black silhouette of a cat-like animal on the left side. To the right of the animal is the text "MAXTER" in bold, capitalized letters. Below the company name is the text "GLOVE MANUFACTURING SDN. BHD. (229652-H)".

## LOT 6070

Jalan Haji Abdu! Manan, 6th Miles Off Jalan Meru, 41050 Klang, Selangor, Malaysia. Tel: [phone] (8 Lines) Fax: [phone] E-MAIL: maxter@tm_net.my

## INDICATIONS FOR USE

Applicant:

Maxter Glove Manufacturing Sdn. Bhd.

510(K) Number (if known):

K113100

Device Name:

Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (Non-Sterile)

Indications For Use:

A powder free 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection<br>Time (Minutes) |
|-------------------------------------------------|--------------------------------------------------|
| Cisplatin, 1.0mg/ml (1,000ppm) | >240 |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 0.53 |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 |
| Fluorouracil, 50.0mg/ml (50,000ppm) | >240 |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 |
| Thiotepa, 10.0mg/ml (10,000ppm) | 75.54 |

Please note that the following drugs have low permeation time of less than 240 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 (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Elijah D. Williams

neurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113100