NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES

K011792 · Latexx Partners Bhd. · LZA · Aug 1, 2001 · General Hospital

Device Facts

• Record ID: K011792
• Device Name: NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
• Applicant: Latexx Partners Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Non-chlorinated, Polymer Coated, Powder Free Nitrile Examination Gloves, Blue Color 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 examination glove; blue color; powder-free; polymer-coated. Worn by healthcare personnel to provide a protective barrier against contamination between user and patient. Manufactured from nitrile rubber compound; processed via washing to remove powder. Used in clinical settings. Provides physical barrier protection.

Clinical Evidence

No clinical tests were conducted. Evidence consists of non-clinical laboratory and animal-based testing, including primary skin irritation and delayed contact sensitization studies in rabbits and guinea pigs, respectively. The product met all performance and biocompatibility requirements per ASTM D 6319-00a and 21 CFR 800.20. Starch presence was negative via USP iodine test.

Technological Characteristics

Nitrile rubber compound; polymer-coated; powder-free. Meets ASTM D 6319-00a standard specifications. Blue color. Non-sterile. No electronic or software components.

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 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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## <011792

## 510(k) SUMMARY

AUG 1 2001

## NON-CHLORINATED, POLYMER COATED, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE COLOR

| 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 | May 12, 2001 |
| Name of Device | |
| Trade Name | NON-CHLORINATED, POLYMER COATED,<br>POWDER FREE NITRILE EXAMINATION GLOVES,<br>BLUE COLOR |
| Common Name | Nitrile examination gloves |
| Classification Name | Patient Examination Gloves |
| Description of the Device | Non-chlorinated, Polymer Coated, Powder Free Nitrile<br>Examination Gloves, Blue Color meet the current<br>ASTM Standard Specification for Nitrile Examination<br>Gloves for Medical Application. It also meets all the<br>current specifications listed under the ASTM<br>Specification D 6319-00a, Standard Specification for<br>Nitrile Examination Gloves. They are blue in colour<br>and are powder free. |
| Intended Use of the Device | Non-chlorinated, Polymer Coated, Powder Free Nitrile<br>Examination Gloves, Blue Color are intended for<br>single use for medical purposes that is worn on the<br>hand of health care and similar personnel to prevent<br>contamination between the health care personnel and<br>the patients. |
| Summary of Technological Characteristics<br>compared to the Predicate Device | There is no different technological characteristic.<br>Gloves are made from nitrile rubber compound and<br>the initial products are powdered Nitrile rubber gloves.<br>These gloves are then further processed into powder<br>free gloves using the existing technology, i.e. washing<br>process. |
| Brief Discussion of Non-clinical Tests | Testing performed per ASTM D 6319-00a Nitrile<br>Examination Gloves for Medical Application and 21<br>CFR 800.20. Gloves meet all the current ASTM<br>Standard Specification for Nitrile Examination Gloves<br>for Medical Application.<br>Primary skin irritation testing in the rabbit and delayed<br>contact sensitization testing in the guinea pig indicate<br>no irritation of sensitization.<br>Final product is negative for the presence of starch<br>using the USP iodine test. |
| Brief Discussion of Clinical Tests | No new clinical tests were conducted under this<br>510(k). |
| Conclusions Drawn for the Non-clinical and<br>Clinical Tests | Non-clinical laboratory and animal based test data<br>indicate that the powder-free product meets all<br>performance and biocompatability requirements. |
| Other Information Deemed Necessary by FDA | Not applicable. |

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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 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 abstract shapes, possibly representing human figures or waves.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2001

Latexx Partners Bhd. C/O Ms. Christina Smith Consultant Smith Associates P.O. Box 4341 Crofton, Maryland 21114

Re : K011792 Trade/Device Name: Non-Chlorinated, Polymer Coated Powder-Free Nitrile Examination Gloves 880.6250 Requlation Number: Regulatory Class: I Product Code: LZA Dated: June 8, 2001 June 8, 2001 Received:

Dear Ms. Smith:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory

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Page 2 - Ms. Smith

In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ents response on fight on 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.

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 marketed produces overmits 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 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 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Clulalorst

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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## INDICATIONS FOR USE

| Applicant | LATEXX MANUFACTURING SDN.BHD.<br>PT 5054, Kamunting Industrial Estate<br>P.O. Box 9<br>34600 Taiping Perak<br>MALAYSIA |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K011792 * |
| Device Name | NON-CHLORINATED, POLYMER COATED,<br>POWDER FREE NITRILE EXAMINATION GLOVE,<br>BLUE COLOR |

Indications For Use

Powder Free Nitrile Examination Glove, Blue Color 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)

Chiu S. Lin

(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