POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).

K090412 · Gx Corporation Sdn Bhd · LZA · Jun 1, 2009 · General Hospital

Device Facts

• Record ID: K090412
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).
• Applicant: Gx Corporation Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jun 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is tested for use with Dacarbazine (DTIC), Mitomycin C, Methotrexate, Cyclophosphamide (Cytoxan), Mitoxantrone, Doxorubicin Hydrochloride, Ifosfamide (Ifex), 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol), Vincristine Sulfate Warning: Not Recommended For Use With Carmustine and Thio-Tepa

Device Story

Disposable nitrile examination glove; worn by healthcare providers during patient examinations to prevent cross-contamination. Material formulated to exclude thiuram, carbamate, and thiazole to reduce dermatitis potential. Tested for permeation resistance against specific chemotherapy agents (Dacarbazine, Mitomycin C, Methotrexate, Cyclophosphamide, Mitoxantrone, Doxorubicin Hydrochloride, Ifosfamide, 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel, Vincristine Sulfate). Not intended for use with Carmustine or Thio-Tepa. Used in clinical settings; provides barrier protection for the examiner.

Clinical Evidence

No clinical data. Bench testing only, specifically permeation testing for chemotherapy drugs.

Technological Characteristics

Nitrile examination glove; powder-free. Formulated without thiuram, carbamate, or thiazole accelerators. Designed for low dermatitis potential. Tested for chemotherapy drug permeation resistance.

Indications for Use

Indicated for use as a patient examination glove to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs; not recommended 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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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN - 1 2009

Mr. Foo Khon Pu Chief Executive Officer GX Corporation SDN BHD Lot 6487-A, Batu 5 34, Semnta, Jalan Kapar Klang Selangor Darul Ehsan MALAYSIA 42100

Re: K090412

Trade/Device Name: Powder Free Nitrile Examination Glove (Pink, Green, Orange, White), This Product Does Not Contain Thiuram, and/or Carbamate and /or Thiazole. Low Dermatitis Potential.

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: May 12, 2009 Received: May 14, 2009

Dear Mr. Pu:

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.

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### Page 2- Ms. Mulnick

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely vours.

Susan Tanner

Susan Runner, D.D.S., MA 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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# Indications for Use

### 510(k) Number (if known): K 090412

Powder Free Nitrile Examination Glove (Pink, Green, Orange, White). Device Name: This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole, Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs.

Indication For Use:

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This glove is tested for use with Dacarbazine (DTIC), Mitomycin C, Methotrexate, Cyclophosphamide (Cytoxan), Mitoxantrone, Doxorubicin Hydrochloride, Ifosfamide (Ifex), 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol), Vincristine Sulfate

Warning: Not Recommended For Use With Carmustine and Thio-Tepa

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 IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Shila A. Murphy MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number

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