SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2

K041436 · Terang Nusa Sdn Bhd · KGO · Aug 20, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041436
• Device Name: SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2
• Applicant: Terang Nusa Sdn Bhd
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

NUZONE X2 surgical gloves are disposable and sterile devices intended to be worn by healthcare personnel to prevent cross contamination between the user and the patient during procedures.

Device Story

NUZONE X2 is a sterile, powder-free, polymer-coated synthetic surgical glove composed of neoprene and polyisoprene. Designed for use by operating room personnel, the glove acts as a physical barrier to prevent cross-contamination between the wearer and the patient, specifically protecting surgical wounds. The device is disposable and intended for manual application by healthcare staff during surgical procedures.

Clinical Evidence

No clinical data. Bench testing only. Device meets ASTM D 3577-01a2 requirements for physical properties and ASTM F 719-81/F 720-81 for primary skin irritation and dermal sensitization.

Technological Characteristics

Material: Neoprene-polyisoprene synthetic blend. Form factor: Powder-free, polymer-coated surgical glove. Standards: ASTM D 3577-01a2 (physical properties), ASTM F 719-81 (skin irritation), ASTM F 720-81 (dermal sensitization). Sterilization: Sterile.

Indications for Use

Indicated for use by operating room personnel to protect a surgical wound from contamination. Intended for use as an over-the-counter device.

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.

Predicate Devices

• NUZONE Nitrile Surgical Gloves Powderfree

Submission Summary (Full Text)

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K041436

### TERANG NUSA Sdn Bhd

and the comments of the

510(k) Submission for NUZONE X2 Surgical Glove Powderfree

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AUG 2 0 2004

# 510(k) Summary

| Submitter Name | Terang Nusa Sdn Bhd |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address | 1, Jalan 8<br>Pengkalan Chepa 2 Industrial Zone<br>16100 Kota Bharu,<br>Kelantan, Malaysia. |
| Submitter Telephone | [phone] |
| Submitter Fax | [phone] |
| Contact Person | LOW, Chin Guan |
| Date of preparation | 09 May 2004 |
| Trade Name | NUZONE X2 |
| Common Name | Sterile Neoprene - Polyisoprene Synthetic surgical<br>glove, Powderfree, Polymer coated. |
| Classification | Surgeon's Glove |
| Legally marketed device to which<br>substantial equivalence is being<br>claimed. | The NUZONE X2, described in this 510(k) is<br>substantially equivalent to the NUZONE Nitrile<br>Surgical Gloves Powderfree that is currently<br>marketed. |
| Description of device | NUZONE X2 ,powderfree surgical glove meets the<br>requirements for surgical gloves described by the<br>American Standard for Testing and Material<br>ASTM D 3577 - 01a2. |
| Intended Use of the device | NUZONE X2 surgical gloves are disposable and<br>sterile devices intended to be worn by<br>healthcare personnel to prevent cross<br>contamination between the user and the patient<br>during procedures. |

### 510 K Summary ( continued)

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510(k) Submission for NUZONE X2 Surgical Glove Powderfree

| Brief description of non-clinical tests | Test conducted per ASTM D 3577 – 01a², ASTM D512 indicates that the product meet the requirements. |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Primary Skin Irritation test ASTM F 719-81 and Dermal Sensitization Test ASTM F 720-81 (86) indicates no sensitization or irritation. |
| Brief description of clinical tests | Not required |
| Conclusion drawn from clinical and non clinical tests | It can be concluded that NUZONE X2 Neoprene - Polyisoprene synthetic powderfree surgical glove will perform according to the performance standards referenced and therefore meets ASTM standards. FDA requirements and labeling claims. This device is substantially equivalent to the currently marketed devices. |
| Additional information deemed necessary by the FDA | None |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three curved lines, resembling a human figure or abstract design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2004

Mr. Chin-Guan Low Director Terang Nusa SDN BHD 1. Jalan 8. Pengkalan Chepa 2 Industrial Zone, 16100 Kota Bharu, MALAYSIA

Re: K041436

Trade/Device Name: Neoprene-Polyisoprene Synthetic Surgical Glove-Powderfree NUZONE X2 Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 6, 2004 Received: August 9, 2004

Dear Mr. Low:

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 Federal Register.

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Page 2 - Mr. Low

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 modi that I Dr I has made statutes and regulations administered by other Federal agencies. or the Act of any I ederal star s requirements, including, but not limited to: registration 1 ou inust comply with and 807); labeling (21 CFR Part 801); good manufacturing practice tina libing (2) early 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) rms reter notification. The FDA finding of substantial equivalence of your device to a premaired 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), 11 you 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/dsma/dsmamain.html

Sincerely yours,

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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TERANG NUSA San Bhd

510(k) Submission for NUZONE X2 Surgical Glove Powderfree

#### 3. Indication for use Statement

| Submitter | : Terang Nusa Sdn Bhd |
|---------------|--------------------------------------------------------------------|
| 510(k) Number | : K041436 |
| Device Name | : Neoprene - Polyisoprene Synthetic Surgical Glove -<br>Powderfree |
| Trade Name | : NUZONE X2 |

Indication 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 (Per 21 CFR 801 Subpart D) ાર

Over the counter X ( 21 CFR 807 Subpart C ) ﺔ ﺍﻟﻤﺮﺍﺟﻊ

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

Concurrence of CDHR Office of Device Evaluation (ODE)

Ke Muly

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

510(k) Number: K041436