NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR

K051562 · Terang Nusa Sdn Bhd · KGO · Oct 20, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051562
• Device Name: NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR
• Applicant: Terang Nusa Sdn Bhd
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

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

Device Story

NUZONE SYNGARD is a sterile, disposable, powder-free, polymer-coated polyisoprene surgical glove; green in color; coated with aloe vera. Device worn by healthcare personnel in operating rooms to provide a barrier preventing cross-contamination between user and patient. Device functions as a physical protective barrier. No electronic, software, or algorithmic components involved.

Clinical Evidence

No clinical data. Bench testing only. Device conforms to ASTM D3577-01a-2 for physical properties and ASTM F719-81/F720-81 for primary skin irritation and dermal sensitization.

Technological Characteristics

Material: Polyisoprene synthetic rubber. Coating: Polymer and Aloe Vera. Form factor: Sterile surgical glove. Standards: ASTM D3577-01a-2 (physical properties), ASTM F719-81 (skin irritation), ASTM F720-81 (dermal sensitization).

Indications for Use

Indicated for use by operating room personnel to protect a surgical wound from contamination. Device is made of synthetic rubber.

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

• Aloe Touch powder free polymer coated polyisoprene surgical gloves (K040503)

Submission Summary (Full Text)

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K05/562

TERANG NUSA Sdn Bhd

510(k) Submission for NUZONE SYNGARI) Surgical Glove Powderfree

# 510(k) Summary

Submitter Name

Submitter Address

Terang Nusa Sdn Bhd

1 . Jalan 8 Pengkalan Chepa 2 Industrial Zone 16100 Kota Bharu, Kelantan . Malaysia.

Submitter Telephone

Submitter Fax

Contact Person

Date of preparation

Trade Name

Common Name

Classification

Legally marketed device to which substantial equivalence is being claimed.

Description of device

Intended Use of the device

160 9 7747171

[phone]

LOW . Chin Guan

May 19, 2004

NUZONE SYNGARD

Powder Free Polymer Coated Poly isoprene Sterile Surgical Glove-Aloe Vera Coated Green Colour.

Surgeon's Glove

The NUZONE SYNGARD, described in this 510(k) is substantially equivalent to the Aloe Touch powder free polymer coated polvisoprene surgical gloves, sterile, coated with aloe ver, Natural colour or turquoise (blue/green) colour that is currently marketed under 510K No. K040503.

NUZONE SYNGARD, powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing ASTMID 3577 - 01a-2. and Material

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

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## TERANG NUSA Sdn Bhd

510(k) Submission for NUZONE SYNGARD Surgical Glove Powderfree

### 510 K Summary ( continued)

| Brief description of non-clinical<br>tests | Test conducted per ASTM D 3577 -- 01a°2, ASTM<br>D512 indicates that the product meet the<br>requirements. |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Testing to conform to the Primary Skin Irritation<br>test ASTM F 719-81 and Dermal Sensitization Test<br>ASTM F 720-81. Polyisoprene is not a primary<br>skin irritant. |
| Brief description of clinical tests | Not required |
| Conclusion drawn from clinical and<br>non clinical tests | It can be concluded that NUZONE SYNGARD<br>Powder Free Polymer Coated Polyisoprene Sterile<br>Surgical Glove-Aloe Vera Coated Green Colour<br>glove will perform according to the performance<br>standards referenced and therefore meets ASTM<br>standards. FDA requirements and labeling claims. |
| | This device is substantially equivalent to the<br>currently marketed devices. |
| Additional information deemed<br>necessary by the FDA | None |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three horizontal lines below the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2005

Mr. Chin-Guan Low Managing Director TERANG NUSA SDN BHD 1. Jalan 8, Pengkalan Chepa 2 Industrial Zonc Kota Bharu, Kelantan MALAYSIA 16100

Re: K051562

KUJ1502
Trade/Device Name: NUZONE SYNGARD Powder Free Polymer Coated Polyisoprene
Trade/Device Name: NUZONE SYNGARD Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove Aloe Vera Coated Green Colour Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: September 27, 2005 Received: October 5, 2005

Dear Mr. Low:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became in 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 cnactment date of the Medical Device Interstate commerce pror to that have been reclassified in accordance with the provisions of Amendinens, of to devrees mat martic Act (Act) that do not require approval of a premarket the rederal Pood, Drug, and Ocometto , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the rec. "The girls 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 If your device is classified (500 additional controls. Existing major regulations affecting (PMA), It may be subject to have adata frederal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sous nouncements 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 Please be advised that I DA 3 issualled on that your device complies with other requirements mean that I DA has made a determinations administered by other Federal agencies. of the Act of ally i ederal statues and regisments, including, but not limited to: registration You must comply with an the Fict b rog 21 CFR Part 801); good manufacturing practice and ilsung (21 CFR Part 607), labeling (21 CFR Part 820); and if requirents as set form in the quarty of closed on (S) (Sections 531-542 of the Act); applicable, the clectionic product laulow you to begin marketing your device as described 21 CFK 1000-1030. This letter will and would be of substantial equivalence In your Section 910(x) promative no oredicate 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), If you desire specific advice for Jour de at [phone]. Also, please note the regulation prease contact the Other or Somments to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inay other general mironmentoners, International and Consumer Assistance at its toll-free Division [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sydtie y. Michie Omd.

Chu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K051562

Device Name: Powder Free Polymer Coated Polyisoprene sterile surgical Glove Aloe vera coated green colour. Indications For Use:

This Sugeon's Glove is a device made of synthetic rubber 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)

Cat. Aid-for Hurricane Katrina 10/7/05

Division of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number:

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