BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES

K034052 · Latexx Manufacturing Sdn.Bhd. · LZA · Mar 15, 2004 · General Hospital

Device Facts

• Record ID: K034052
• Device Name: BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
• Applicant: Latexx Manufacturing Sdn.Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Black Colour Powder Free 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

Black nitrile rubber examination glove; single-use; worn on hands by healthcare personnel. Prevents cross-contamination between clinician and patient. Manufactured from nitrile rubber latex compound; processed into powder-free state via chlorination and multiple rinsing. Used in clinical settings. Provides barrier protection.

Clinical Evidence

No clinical tests conducted. Bench testing performed per ASTM D 6319-00a and 21 CFR 800.20. 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 latex compound; powder-free; black color. Manufacturing process includes chlorination and multiple rinsing. Complies with ASTM D 6319-00a. Single-use, non-sterile.

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

• Class I patient examination glove (80LZA) (21CFR 880.6250)

Submission Summary (Full Text)

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MAR 1 5 2004

Attachment 16

Black Colour Powdered Nitrile Rubber Examination Gloves

K034052

## 510(k) SUMMARY

# PRE-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 5555 |
| Submitter 's Fax Number | 605 891 1088 |
| Name of Contact Person | Lim Chian Chian |
| Date of Preparation | December 15, 2003 |
| Name of Device | |
| Trade Name | : Black Colour Powder Free Nitrile Rubber Examination<br>Glove |
| Common Name | : Nitrile Rubber Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Legally Marketed Device to Which Equivalency<br>is Being Claimed | Black Colour Powder Free<br>Nitrile Rubber Examination<br>Glove as described in this 510k Notification is substantially<br>equivalent to the current Class I patient examination glove<br>bearing the product code 80LZA (21CFR 880.6250).<br>meets all the current specifications listed under the ASTM<br>Specification D 6319-00a, Standard Specification for Nitrile<br>Examination Gloves. |
| Description of the Device | Black Colour Powder Free Nitrile Rubber Examination<br>Glove as described in this 510k Notification is substantially<br>equivalent to the current Class I patient examination glove<br>bearing the product code 80LZA (21CFR 880.6250). It<br>meets all the current specifications listed under the ASTM<br>Specification D 6319-00a, Standard Specification for Nitrile<br>Examination Gloves. They are made from nitrile rubber<br>compound. They are black in colour and are powder free. |
| Intended Use of the Device | Black Colour Powder Free Nitrile Rubber Examination<br>Glove is intended for single use for medical purposes that<br>is worn on the hand of health care and similar personnel to<br>prevent contamination between the health care personnel<br>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 and the initial<br>products are low powdered nitrile gloves.<br>These gloves<br>are then further processed into powder free gloves using<br>the 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 for Medical<br>Application and 21 CFR 800.20. Gloves meet all the<br>current ASTM D 6319-00a Standard Specification for<br>Nitrile Examination Gloves. |
| | Primary skin irritation testing in the rabbit and delayed<br>contact sensitization testing in the guinea pig indicate no<br>irritation or sensitization. |
| | 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 pre-powdered product meets all performance and<br>biocompatibility requirements. |
| Other Information Deemed Necessary by FDA | Not applicable. |

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## Attachment 16

Image /page/1/Picture/2 description: The image contains a sequence of alphanumeric characters that appear to be handwritten. The characters are 'K034252'. The characters are written in a simple, somewhat stylized manner, with varying stroke thicknesses. The image has a white background.

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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 circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2004

Latexx Manufacturing SDN.BHD C/O Mr. Law Siau Woei (Terry Law) Medtexx Partners, Incorporated 216 Charles Street Hackensack, New Jersey 07601

Re: K034052

Trade/Device Name: Black Colour Powder-Free Nitrile Rubber Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 15, 2003 Received: January 26, 2004

Dear Mr. Terry Law:

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. Law

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), please 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 vours.

Ching-Lin, Ph.D.

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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Attachment 2

Black Colour Powder-free Nitrile Rubber Examination Glove

Image /page/4/Picture/2 description: The image shows the logo for LATEXX MANUFACTURING SDN BHD (165989-U). The logo is black and white and features the word "LATEXX" in large, bold letters. To the right of the word is a graphic of three hands. The text "MANUFACTURING SDN BHD (165989-U)" is printed in smaller letters below the logo.

## 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)

K034052

### Device Name

#### BLACK COLOUR POWDER FREE NITRILE RUBBER EXAMINATION GLOVE.

Indications For Use

Black Colour Powder Free Nitrile Rubber Examination Glove 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Martha O'Lone
Interim Branch Chief
Martha O'Lone
Sign Off
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510(k) Number

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