NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE

K110698 · Terang Nusa Sdn Bhd · KGO · Dec 7, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110698
• Device Name: NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE
• Applicant: Terang Nusa Sdn Bhd
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Dec 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

This Surgeons Glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Device Story

Nuzone X2T is a polychloroprene synthetic tan powder-free surgical glove. Designed for use by operating room personnel to maintain sterile fields and protect surgical wounds from contamination. Device provides barrier protection during surgical procedures and is tested for resistance to specific chemotherapy drugs per ASTM D6978-05. Gloves are donned manually by clinicians.

Clinical Evidence

Bench testing only. Device tested for chemotherapy drug permeation per ASTM D6978-05. Breakthrough detection times provided for ten chemotherapy agents; Carmustine and Thiotepa showed low permeation times (5.18 and 3.03 minutes respectively), while others exceeded 240 minutes.

Technological Characteristics

Material: Polychloroprene synthetic rubber. Form factor: Powder-free surgical glove. Testing standard: ASTM D6978-05 for chemotherapy drug resistance.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. Not restricted by age or gender.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

DEC - 7 2011

Mr. Robert Hill Regulatory Manager Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2 Ind. Zone Kota Bharu Kelantan MALAYSIA 16100

Re: K110698

Trade/Device Name: Nuzone X2T Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: December 5, 2011 Received: December 5, 2011

Dear Mr. Hill:

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 - Mr. Hill

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 vours.

Anthony D. mater

Anthony D. Watson, B.S., M.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 the words "TERANG NUSA" in a bold, sans-serif font. To the right of the words is a stylized compass rose or star-like symbol. The text and symbol are both in black, contrasting with the white background.

## Indications for Use

510(k) Number: K110698

Device Name: Nuzone X2T

Description: Polychloroprene Synthetic Tan Surgical gloves Powder Free

Indications for Use: This Surgeons Glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

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)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)________________________________________________________________________________________________________________________________________________________________________

. ------

Shila H. Murphy, MD to B. Blythe Thorne Williams

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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**TERANG NUSA**

510(k) Number: Kl10698 Device Name: Nuzone X2T

## Continued:

These gloves are tested for use with Chemotherapy Drugs.

Testing based on ASTM D6978-05

| DRUG | Breakthrough Detection Time |
|----------------------------------------------------|--------------------------------------|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | Avg. 5.18 (6.55, 5.95, 3.04) Minutes |
| Cisplatin 1.0 mg/ml (1,000 ppm) | Up to 240 Minutes |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) | Up to 240 Minutes |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | Up to 240 Minutes |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | Up to 240 Minutes |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | Up to 240 Minutes |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | Up to 240 Minutes |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | Up to 240 Minutes |
| Thiotepa 10.0 mg/ml (10,000 ppm) | Avg. 3.03 (6.41, 1.63, 1.06) Minutes |
| Vincristine Sulfate 50.0 mg/ml (50,000 ppm) | Up to 240 Minutes |

Please note that the following drugs have extremely low permeation times Carmustine (BCNU) of 5.18 and Thiotepa of 3.03 minutes.