POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)

K122131 · Matang Mfg. Sdn. Bhd. · LZA · Oct 17, 2012 · General Hospital

Device Facts

• Record ID: K122131
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
• Applicant: Matang Mfg. Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Powder Free Nitrile Examination Glove - Blue (Chemotherapy) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. In addition, these Chemotherapy gloves were tested for use with the following drug concentrations per ASTM D 6978-05

Device Story

Disposable nitrile examination glove; worn on examiner's hand/finger; prevents cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs per ASTM D 6978-05. Used in clinical settings by healthcare professionals. Provides barrier protection during patient examination and chemotherapy drug handling.

Clinical Evidence

Bench testing only. Permeation testing performed for 14 chemotherapy drugs per ASTM D 6978-05. Breakthrough detection times reported for all tested agents; Carmustine (60.3 min) and Thiotepa (156.0 min) noted with specific breakthrough times, while others showed no breakthrough up to 240 minutes.

Technological Characteristics

Material: Nitrile. Form factor: Powder-free examination glove. Testing standards: ASTM D 6978-05 for chemotherapy drug permeation. Non-sterile (implied by examination glove classification).

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner. Suitable for use during handling of specific chemotherapy drugs as tested per ASTM D 6978-05.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Matang Manufacturing Sdn. Bhd
Ms. Leslie Leong
Operation Manager
Lot 10, Kawasan Perindustrian Serkam
Mukim Serkam, Merlimau
Melaka, Malaysia 77300

OCT 1 7 2012

Re: K122131

Trade/Device Name: Powder Free Nitrile Examination Glove -- Blue (Chemotherapy). Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: October 4, 2012 Received: October 12, 2012

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

Sincerely yours,

Antheon D. anaton

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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## Premarket Notification For Powder Free Nitrile Examination Glove - Blue (Chemotherapy)

| <b>3.0</b> | <b>Indication For Use Statement</b> |
|------------|-------------------------------------|
|------------|-------------------------------------|

510(K) Number (if known): K122131

Device Name : Powder Free Nitrile Examination Glove - Blue (Chemotherapy)

: A Powder Free Nitrile Examination Glove - Blue Indications For Use (Chemotherapy) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. In addition, these Chemotherapy gloves were tested for use with the following drug concentrations per ASTM D 6978-05

Permeation Test Results

| TEST CHEMOTHERAPY DRUG AND<br>CONCENTRATION | MINIMUM BREAKTHROUGH<br>DETECTION TIME (Specimen<br>1/2/3)(Minutes) |
|----------------------------------------------------|---------------------------------------------------------------------|
| Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) | 60.3<br>(60.3, 60.5, 60.6) |
| Cisplatin, 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 min. |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000ppm) | No breakthrough up to 240 min. |
| Dacarbazine (DTIC), 10.0 mg/ml (10,000 ppm) | No breakthrough up to 240 min. |
| Doxorubicin Hydrochloride, 2.0 mg/ml (2,000 ppm) | No breakthrough up to 240 min. |
| Etoposide (Toposar), 20.0 mg/ml (20,000 ppm) | No breakthrough up to 240 min. |
| Fluorouracil, 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 min. |
| Ifosfamide, 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 min. |
| Methotrexate, 25 mg/ml (25,000 ppm) | No breakthrough up to 240 min. |
| Mitomycin C, 0.5 mg/ml (500 ppm) | No breakthrough up to 240 min. |
| Mitoxantrone, 2 mg/ml (2,000 ppm) | No breakthrough up to 240 min. |
| Paclitaxel (Taxol), 6.0 mg/ml (6,000 ppm) | No breakthrough up to 240 min. |
| Thiotepa, 10.0 mg/ml (10,000 ppm) | 156.0<br>(163.8, 156.0, 165.0) |
| Vincristine Sulfate, 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 min. |

Caution : Testing showed the following drugs have low average breakthrough detection time:

* Carmustine - 60.3 min

* Thiotepa - 156.0 min

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

ter Use √

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

División Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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**510(k) Number:** K 12213