MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES

K022347 · Latexx Manufacturing Sdn.Bhd. · LZA · Aug 15, 2002 · General Hospital

Device Facts

• Record ID: K022347
• Device Name: MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
• Applicant: Latexx Manufacturing Sdn.Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove is intended for single use for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients.

Device Story

Single-use powdered nitrile rubber examination glove; green color. Worn by healthcare and similar personnel on hands to provide barrier protection; prevents cross-contamination between personnel and patients. Manufactured from nitrile rubber latex compound. Used in clinical or medical settings. Device provides physical barrier; no electronic or mechanical components.

Clinical Evidence

No clinical tests were conducted. Non-clinical bench testing performed per ASTM D 6319-00a and 21 CFR 800.20. Biocompatibility testing included primary skin irritation (rabbit) and delayed contact sensitization (guinea pig), demonstrating no irritation or sensitization.

Technological Characteristics

Material: Nitrile rubber latex compound. Form factor: Powdered examination glove. Color: Green. Standards: ASTM D 6319-00a. Sterilization: Not specified. Connectivity: None. Energy source: None.

Indications for Use

Indicated for use by healthcare and similar personnel as a single-use protective barrier worn on the hands to prevent cross-contamination between personnel and patients.

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.

Predicate Devices

• MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove (K022347)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) SUMMARY

40223647

# POWDERED GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES

| Submitter's Name | LATEXX MANUFACTURING SDN. BHD. |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address | PT 5054, Kamunting Industrial Estate |
| | P.O. Box 9, 34600 Taiping, Perak |
| | Malaysia |
| Submitter's Phone Number | 605 891 1111 |
| Submitter 's Fax Number | 605 891 1088 |
| Name of Contact Person | Teoh, Choh Shee |
| Date of Preparation | July 15, 2002 |
| Name of Device | |
| Trade Name | MedtexxTM Powdered Green Colour Nitrile Rubber<br>Examination Glove |
| Common Name | Nitrile Rubber Examination Gloves |
| FDA SE Classification Name | Patient Examination Gloves, Powdered |
| FDA Classification Product Code | Nitrile - 80LZA |
| Legally Marketed Device to Which Equivalency<br>is Being Claimed | MedtexxTM Powdered Green Colour Nitrile Rubber<br>Examination Glove as described in this 510k Notification is<br>substantially equivalent to the current Class I patient<br>examination glove bearing the product code 80LZA<br>(21CFR 880.6250). It meets all the current specifications<br>listed under the ASTM Specification D 6319-00a, Standard<br>Specification for Nitrile Examination Gloves for Medical<br>Application. |
| Description of the Device | MedtexxTM Powdered Green Colour Nitrile Rubber<br>Examination Glove meets all the current specifications<br>listed under the ASTM Specification D 6319-00a, Standard<br>Specification for Nitrile Examination Gloves for Medical<br>Application. They are made from nitrile rubber latex<br>compound. They are green in color and are powdered. |
| Intended Use of the Device | MedtexxTM Powdered Green Colour Nitrile Rubber<br>Examination Glove is intended for single use for medical<br>purposes that is worn on the hand of health care and<br>similar personnel to prevent contamination between the<br>health care personnel and the patients. |
| Summary of Technological Characteristics<br>Compared to the Predicate Device | There is no different technological characteristic. Gloves<br>are made from nitrile rubber latex compound. |
| Brief Description of Non-clinical Tests | Testing performed per ASTM D 6319 - 00a, Standard<br>Specification for Nitrile Examination Gloves for Medical<br>Application and 21 CFR 800.20. Gloves meet all the<br>current ASTM D 6319-00a.<br>Primary skin irritation testing in the rabbit and delayed<br>contact sensitization testing in the guinea pig indicate no<br>irritation or sensitization. |
| Brief Description of Clinical Tests | No new clinical tests were conducted under this 510(k). |
| Conclusions Drawn from the Non-clinical and<br>Clinical Tests | Non-clinical laboratory and animal based test data indicate<br>that the pre-powdered product meets all performance and<br>biocompatibility requirements. |
| Other Information Deemed Necessary by FDA | Not applicable. |

{1}------------------------------------------------

・

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or faces, depicted in a flowing, abstract manner.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 5 2002

Mr. Teoh Choh Shee General Manager Latexx Manufacturing Sdn. Bhd. PT. 5054, P.O. Box 9 Kamunting Industrial Estate Taiping, Perak, MALAYSIA

Re: K022347

Trade/Device Name: Medtexx™ Green Colour Powdered Nitrile Rubber Examination Gloves Regulation Number:880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 15, 2002 Received: July 19, 2002

Dear Mr. Shee:

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.

{3}------------------------------------------------

and the comments of the country

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Runner

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Attachment 2

Medtexx™ Green Colour Powdered Nitrile Rubber Examination Gloves

:

.

Image /page/4/Picture/2 description: The image shows the logo for Latexx Manufacturing SDN BHD (165989-U). The logo consists of the word "LATEXX" in a bold, sans-serif font, with a horizontal line underneath. To the right of the word is a graphic of a hand.

## INDICATIONS FOR USE

Applicant

LATEXX MANUFACTURING SDN.BHD. PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA

510(k) Number (if known)

K022347

Device Name

#### POWDERED NITRILE RUBBER EXAMINATION GLOVE, GREEN COLOUR.

Indications For Use

Powdered Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Concurrence of CDRH Office of Device Evaluation (ODE)

Qhin S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number

Prescription Use Per 21 CFR 801,109

OR

Over-The-Counter