CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES

K022346 · Latexx Manufacturing Sdn.Bhd. · LZA · Oct 18, 2002 · General Hospital

Device Facts

• Record ID: K022346
• Device Name: CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES
• Applicant: Latexx Manufacturing Sdn.Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Cleantexx™ Mint Flavour, Blue Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves 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

Synthetic rubber examination glove; manufactured from BarrierPro polybutadiene-based copolymer latex. Device is mint-flavored, blue-colored, and powder-free. Used in clinical settings by healthcare personnel as a protective barrier to prevent cross-contamination between the wearer and the patient. Device is donned manually by the user. Provides a physical barrier to reduce exposure to contaminants during medical examinations.

Clinical Evidence

No clinical tests were conducted. Evidence is based on non-clinical laboratory and animal testing. Bench testing confirmed compliance with ASTM D 6319-00a. Biocompatibility testing (primary skin irritation in rabbits and delayed contact sensitization in guinea pigs) showed no irritation or sensitization. Final product tested negative for starch using USP iodine test.

Technological Characteristics

Material: BarrierPro synthetic polybutadiene copolymer rubber. Form factor: Powder-free examination glove. Standards: ASTM D 6319-00a. Processing: Multiple washing and rinsing cycles to achieve powder-free status. Biocompatibility: Non-irritating and non-sensitizing per animal studies.

Indications for Use

Indicated for use by healthcare and similar personnel as a single-use protective barrier on the hand 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 (Product Code 80LZA)

Submission Summary (Full Text)

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## OCT 1 8 2002

## 510(k) SUMMARY

# 1022346

CLEANTEXX™ MINT FLAVOUR, BLUE COLOUR POWDER FREE BARRIER PRO™ POLYBUTADIENE COPOLYMER 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 | June 28, 2002 |
| Name of Device | |
| Trade Name | Cleantexx ^TM Mint Flavour, Blue Colour Powder Free Barrier<br>Pro ^TM Polybutadiene Copolymer Examination Gloves |
| Common Name | Synthetic Rubber Examination Gloves |
| FDA SE Classification Name | Patient Examination Gloves, Powder-free |
| FDA Classification Product Code | Nitrile - 80LZA |
| Legally Marketed Device to Which Equivalency<br>is Being Claimed | Cleantexx ^TM Mint Flavour, Blue Colour Powder Free Barrier<br>Pro ^TM Polybutadiene Copolymer Examination Gloves as<br>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 for Medical Application. |
| Description of the Device | Cleantexx ^TM Mint Flavour, Blue Colour Powder Free Barrier<br>Pro ^TM Polybutadiene Copolymer Examination Gloves<br>meets all the current specifications listed under the ASTM<br>Specification D 6319-00a, Standard Specification for Nitrile<br>Examination Gloves for Medical Application. They are<br>made from BarrierPro ^TM synthetic copolymer rubber latex, a<br>polybutadiene based copolymer. They are mint flavour,<br>blue in colour, are powder free. |

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| Intended Use of the Device | Cleantexx™ Mint Flavour, Blue Colour Powder Free Barrier<br>Pro™ Polybutadiene Copolymer Examination Gloves is<br>intended for single use for medical purposes that is worn<br>on the hand of health care and similar personnel to prevent<br>contamination between the health care personnel and the<br>patients. |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Technological Characteristics<br>Compared to the Predicate Device | There is no different technological characteristic. Gloves<br>are made from BarrierPro™ (Trade Mark of Reichhold<br>Chemicals, Inc. of USA) synthetic butadiene copolymer<br>compound and the initial products are low powdered<br>synthetic copolymer gloves. These gloves are then further<br>processed into powder free gloves using the existing<br>technology, i.e. multiple washing ad rinsing 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

OCT 1 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Teoh Choh Shee General Manager Latexx Manufacturing Sdn Bhd PT 5054, Jalan Perusahaan Tiga, Kamunting Industrial Estate, P. O. Box 9, 34600 Kamuting, Taiping, Perak, MALAYSIA

Re: K022346

Trade/Device Name: Cleantexx™ Mint Flavour, Blue Colour Powder Free BarrierPro™ Polybutadience Copolymer Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 26, 2002 Received: October 1, 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.

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Page 2 – Mr. Shee

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.gov/cdrh/dsma/dsmamain.html

Sincerely yours

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

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Cleantexx 7M Mint Flavour, Blue C Powder-free Barrier Pro TM Polybutadien Copolymer Examination Gloves

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 with a horizontal line underneath. To the right of the word is a black circle with white lines inside, resembling 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)

K022346 *

Device Name

MINT FLAVOUR, BLUE COLOUR POWDER FREE BARRIERPROA COPOLYMER RUBBER EXAMINATION GLOVE

Indications For Use

. .

Mint Flavour, Blue Colour Powder Free BarrierPro™ Copolymer 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.

Concurrence of CDRH Office of Device Evaluation (ODE)

Chin S. Lim

Division of Anesthesinhay General Hospital Infection Control. Denta

510(k) Number. K022342

Prescribtion Use