NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE

K990840 · Terang Nusa Sdn Bhd · LZA · May 17, 1999 · General Hospital

Device Facts

• Record ID: K990840
• Device Name: NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
• Applicant: Terang Nusa Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: May 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

These powderfree nitrile examination gloves are to be worn by healthcare workers or similar personnel during work to prevent cross contamination between the user and the patient.

Device Story

Nugard Nitril is a blue, powder-free nitrile patient examination glove. Used by healthcare workers or similar personnel in clinical settings to provide a barrier against cross-contamination between the user and the patient. Device is a disposable physical barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data. Bench testing conducted per ASTM D3578 and ASTM D512 standards. Biocompatibility testing performed.

Technological Characteristics

Material: Nitrile. Form factor: Blue, powder-free examination glove, sizes XS-XL. Standards: ASTM D3578, ASTM D512. No electronic components or software.

Indications for Use

Indicated for use by healthcare workers or similar personnel to prevent cross-contamination between the user and the patient.

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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K 990840

Image /page/0/Picture/1 description: The image shows a black and white drawing of a compass rose. The compass rose has eight points, with each point being a sharp, elongated triangle. There are two curved shapes on either side of the compass rose, which may be decorative elements. The image is simple and graphic, with a focus on the geometric shapes of the compass rose.

## TERANG NUSA Sdn Bhd

510(k) Summary for NUGARD Powderfree Nitrile Examination Glove

### MAY 1 7 1999

# 510(k) Summary

| Submitter Name | Terang Nusa Sdn Bhd |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address | E4(4), Jalan 8<br>Pengkalnn 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 | 8 Mar 99 |
| Trade Name | Nugard Nitril |
| Common Name | Examination Glove |
| Classification | Patient Examination Glove |
| Legally marketed device to which<br>substantial equivalence is being<br>claimed. | The Nugard Nitril powderfree examination glove<br>described in this 510(k) is substantially equivalent<br>to the powderfree nitrile examination glove<br>currently being marketed. |
| Description of device | Nugard Nitril meet the requirement for<br>examination glove described by the American<br>Standard for Testing and Material ASTM D 3578<br>with the exception of ultimate elongation before<br>aging. It is blue in color. Sizes available is from<br>XS - XL |
| Intended Use of the device | These powderfree nitrile examination gloves<br>are to be worn by healthcare workers or similar<br>personnel during work to prevent cross<br>contamination between the user and the<br>patient. |
| Summary of technological<br>characteristics compared to<br>predicate device | This notification describes the similarities to the<br>approved device described. |
| Brief description of non-clinical<br>tests | Test conducted per ASTM D3578, ASTM D512<br>indicates that the product meet the requirements.<br><br>Biocompatibility tests are carried out. |
| Brief description of clinical tests | Not carried out |
| Conclusion drawn from clinical and<br>non clinical tests | Not applicable |
| Additional information deemed<br>necessary by the FDA | None |

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Image /page/1/Picture/0 description: The image shows a compass rose, a figure used on maps to display the orientation of the cardinal directions. The compass rose is black and white and has eight points. There is a faint dotted line that appears to be a drawing of a plane flying around the compass rose.

## TERANG NUSA Sdn Bhd

510(k) Summary for NUGARD Powderfree Nitrile Examination Glove

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with three lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 1999

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

Re : K990840 NUGARD Nitril® Powder-Free Nitrile Trade Name: Examination Glove, Blue Regulatory Class: Product Code: LZA Dated: March 31, 1999 Received: April 6, 1999

Dear Mr. Chin-Guan Low:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਮੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Chin-Guan Low

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Figure/0 description: The image shows a compass rose with eight points. The compass rose is black and white. There are some faint outlines of buildings in the background, but they are not very clear.

ر پرم

彩神彩

线

#### TERANG NUSA Sdn Bhd

510(k) Submission for Powderfree Nitrile Examination Glove

#### 3. Indication for use Statement

| Applicant | : | Terang Nusa Sdn Bhd |
|---------------|---|---------------------------|
| 510(k) Number | : | Not available K990840 |
| Device Name | : | Patient Examination Glove |
| Trade Name | : | NUGARD Nitril®, Blue |

Indication for use

The examination gloves are to be worn by healthcare workers or similar personnel during work to prevent cross contamination between the user and the patient.

Concurrence of CDHR Office of Device Evaluation (ODE)

Zare N. br Chin

sion Sign-Off) Division of Dental, Infection Control, and General Hospital Devices Kggr84C 510(k) Number _

Prescription Use Per 21 CFR 801.109 OR

Over the counter