NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED

K051563 · Terang Nusa Sdn Bhd · KGO · Jun 20, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051563
• Device Name: NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED
• Applicant: Terang Nusa Sdn Bhd
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jun 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

This surgical glove is a device made of a neoprene – polyisoprene synthetic material intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Nuzone X2A is a sterile, powder-free surgical glove composed of a neoprene-polyisoprene synthetic blend. The glove features a polymer and aloe vera coating and is available in natural or green colors. It is intended for use by operating room personnel to provide a protective barrier, preventing contamination of surgical wounds during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Neoprene-polyisoprene synthetic blend; Coating: Polymer and aloe vera; Form: Powder-free, sterile surgical glove; Colors: Natural or green; Regulation: 21 CFR 878.4460; Product Code: KGO.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2005

Mr. Low Chin Guan Managing Director Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2 Industrial Zone Kota Bharu, Kelantan, MALAYSIA 16100

Re: K051563

Trade/Device Name: Nuzone X2A, Neoprene-Polyisoprene Blend Powder Free Sterile Surgical Glove Polymer andA Aloe Vera Coated Natural or Green Colour Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 23, 2005 Received: June 13, 2005

Dear Mr. Chin Guan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Chin Guan

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours.

Judite Y. Mohin Omd

Chiu Lin, Ph.D. 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):

Device Name: Nuzone X2A , Neoprene - Polyisoprene Blend Powder Free sterile surgical Glove Polymer andAloe vera coated natural or green colour. Indications For Use:

This surgical glove is a device made of a neoprene – polyisoprene synthetic material intended to be worn by operating room personnel to protect a surgical wound from contamination.

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)

Sheila K. Murphy, KS 4/17/05

Anesthesiology, General Hospital Infection Control. Dental

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510(k) Number: A 051563