MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES

K022548 · Latexx Manufacturing Sdn.Bhd. · LZA · Aug 15, 2002 · General Hospital

Device Facts

• Record ID: K022548
• Device Name: MEDTEXX BLUE COLOUR POWDER-FREE 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

Medtexx Blue Colour Powder Free Nitrile Rubber Examination Gloves are 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 nitrile rubber examination glove; blue color; powder-free. Worn on hands by healthcare personnel to provide barrier protection against contamination. Manufactured via nitrile rubber compound; processed using chlorination and multiple rinsing to achieve powder-free status. Used in clinical settings for patient examination.

Clinical Evidence

No clinical tests conducted. Bench testing performed per ASTM D 6319-00a. Biocompatibility testing (primary skin irritation in rabbits, delayed contact sensitization in guinea pigs) showed no irritation or sensitization. USP iodine test confirmed absence of starch.

Technological Characteristics

Nitrile rubber compound; powder-free; blue color. Manufacturing involves chlorination and multiple rinsing. Meets ASTM D 6319-00a specifications.

Indications for Use

Indicated for single use by healthcare and similar personnel 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

• Medtexx Blue Colour Powder Free Nitrile Rubber Examination Glove (80LZA/80LYY)

Submission Summary (Full Text)

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AUG 1 5 2002

## 510(k) SUMMARY

Y022548

## MEDTEXX™ BLUE COLOUR POWDER FREE
NITRILE RUBBER EXAMINATION GLOVES

| Submitter's Name | LATEXX MANUFACTURING SDN. BHD. |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address | PT 5054, Kamunting Industrial Estate<br>P.O. Box 9, 34600 Taiping, Perak<br>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 30, 2002 |
| Name of Device | |
| Trade Name | Medtexx™ Blue Colour Powder Free Nitrile Rubber<br>Examination Glove |
| Common Name | Synthetic Rubber Examination Gloves |
| Classification Name | Patient Examination Gloves |
| Legally Marketed Device to Which<br>Equivalency is Being Claimed | Medtexx™ Blue Colour Powder Free 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 (21CFR<br>880.6250). It meets all the current specifications listed under<br>the ASTM Specification D 6913-00a, Standard Specification<br>for Nitrile Examination Gloves. |
| Description of the Device | Medtexx™ Blue Colour Powder Free Nitrile Rubber<br>Examination Glove is substantially equivalent to the Class 1<br>patient examination glove bearing the product code 80LYY<br>(21CFR 880.6250). It meets all the current specifications<br>listed under the ASTM Specification D 6913-00a, Standard<br>Specification for Nitrile Examination Gloves. They are made<br>from nitrile rubber compound. They are blue in color and are<br>powder free. |
| Intended Use of the Device | Medtexx™<br>Blue Colour Powder Free Nitrile Rubber<br>Examination Gloves are 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 compound and the initial<br>products are low powdered nitrile gloves. These gloves are<br>then further processed into powder free gloves using the<br>existing technology, i.e. chlorination and multiple rinsing<br>processes. |
| Brief Description of Non-clinical Tests | Testing performed per ASTM D 6319-00a. Standard<br>Specification for Nitrile Examination Gloves and 21 CFR<br>800.20. Gloves meet all the current ASTM D 6319-00a<br>Standard Specification for Nitrile Examination Gloves.<br>Primary skin irritation testing in the rabbit and delayed<br>contact sensitization testing in the guinea pig indicate no<br>irritation or sensitization.<br>Final product is negative for the presence of starch using<br>the USP iodine test. |
| 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 powder-free product meets all performance and<br>biocompatibility requirements. |
| Other Information Deemed Necessary by FDA | Not applicable. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are drawn with thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2002

Latexx Manufacturing Sdn. Bhd. C/O Mr. Law Siau Woei Medtexx Partners, Incorproated 216 Charles Street Hackensack, New Jersey 07601

Re: K022548

Trade/Device Name: Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 15, 2002 Received: August 1, 2002

Dear Mr. Woei:

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 vour 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.

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.

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Page 2 - Mr. Woei

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 (OS) 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 yours,

Susan Runge.

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

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Attachment 2

Medtexx™ Blue Colour Powder Free Nitrile Rubber Examination Gloves

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Image /page/4/Picture/2 description: The image shows the logo for "LATEXX MANUFACTURING SDN BHD (165989-U)". The word "LATEXX" is in large, bold, black letters. Below the word is a line, and below the line is the company name and registration number.

## 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)

K022548

Device Name

MEDTEXX™ BLUE COLOUR POWDER FREE NITRILE RUBBER EXAMINATION GLOVE

Indications For Use :

Blue Colour Powder Free Nitrile Rubber Examination Gloves 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)

Chun S. Lim

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

Prescription Use Per 21 CFR 801.109

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Over-The-Counter OR