LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE

K050765 · N.S. Uni-Gloves Sdn. Bhd. · LZA · Apr 8, 2005 · General Hospital

Device Facts

• Record ID: K050765
• Device Name: LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE
• Applicant: N.S. Uni-Gloves Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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 the patient and the examiner.

Device Story

Lano-E Powder-Free Nitrile Examination Glove is a disposable, non-sterile patient examination glove. It is worn on the examiner's hand to provide a barrier against contamination between the patient and the examiner. The device is manufactured from nitrile rubber and features a beaded cuff. It is processed with pharmaceutical-grade lanolin and Vitamin E as emollient and conditioning agents. The gloves are available in sizes XXS through XL and are intended for use in clinical or medical settings. The device is used by healthcare professionals to maintain hygiene and prevent cross-contamination during patient examinations.

Clinical Evidence

Bench testing only. The device was tested for physical properties (tensile strength, ultimate elongation), dimensions, and water-tightness (1000ml water test) in accordance with ASTM D 6319-00 Rev A, EN 455-1/2/3, and ISO 2859-1 standards. Testing was performed both before and after aging.

Technological Characteristics

Material: Nitrile. Features: Beaded cuff, powder-free. Emollients: Lanolin and Vitamin E. Dimensions: 240mm length, 0.10-0.17mm thickness. Standards: ASTM D 6319-00 Rev A, EN 455-1:2000, EN 455-2:2000, EN 455-3:2000, ISO 2859-1:1999, ISO 9001:2000. Physical properties: 14.0 MPa minimum tensile strength, 700% minimum elongation (before aging).

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand to prevent contamination between patient and examiner.

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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#### 2005 APR 8 -

510(k) Number: K050765

# Submission Applicant:

N.S. Uni-Gloves Sdn. Bhd. Lot 3 & 4/4510 Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Telephone No. 60-6-677-2751/2 Malaysia Fax No. 60-6-677-2755

Device Listing No. B 034622 Registration No. 8040880 K050765 510(k) Number:

# Official Correspondent in the United States:

Kenneth J. Stanton, President UG Healthcare (USA) Inc. 2420 Carson St., Suite 125 Torrance, CA 90501

Telephone No .: [phone] Fax No.: [phone]

### Submitted: March 15, 2005

A. Description of the Device Trade Name: Lano-E Powder-Free Nitrile Examination Glove Common Name: Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I Powder-Free Nitrile examination glove 80LZA that meets a all of the requirements of ASTM Standard D 6319 - 00 Rev A

Intended Use of the Device: A 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 the patient and the examiner.

> SUMMARY PREMARKET 510(k) NOTIFICATION For Lano-E Powder-Free Nitrile Examination Gloves K050765 510(k) Number: March 23, 2005

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# Summary of Technological Characteristics:

Powder Residue: Maximum 2mg/glove Material: Nitrile Cuff: Beaded Cuff: Quality Assurance: In compliance with ASTM D6319-00 Rev A, EN 455-3 : 2000, EN 455-2 : 2000, EN 455-1 : 2000, ISO 2859-1:1999 and manufactured under ISO9001:2000

Inspection Parameters:

| Criteria | Inspection Level | AQL |
|-------------------------|------------------|-----|
| Dimensions | S-2 | 4.0 |
| Physical Properties | S-2 | 4.0 |
| Water Tight Test 1000ml | G-1 | 1.5 |
| Visual Major Defects | G-1 | 1.5 |
| Visual Minor Defects | G-1 | 2.5 |

# Physical Properties:

| Dimensions: | |
|-------------------|-----------------------------------------------------|
| Overall Length: | 240 mm minimum |
| Width: | 95 mm minimum (for medium glove) |
| Palm Thickness: | 0.10 to 0.15 mm (at center of palm) |
| Finger Thickness: | 0.10 to 0.17 mm (at 15mm from tip of center finger) |
| Cuff Thickness: | 0.10 to 0.15 mm (at 40mm from the beaded end) |

# BEFORE AGING

AFTER AGING

| Tensile Strength: | 14.0. Mpa minimum |
|----------------------|-------------------|
| Ultimate Elongation: | 700% minimum |
| Pinhole AQL | 1.5 minimum |

14.0 Mpa minimum 500% minimum 1.5 minimum

Special Properties: Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.

Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case

Sizes: XXS - XL

Conclusion: The Lano-E Powder-Free Nitrile Examination Glove meets the physical property requirements of ASTM D 6319-00 Rev A and the FDA 1000 ml water test both before and after aging.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

Public Health Service

2005 APR 8

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

N.S. Uni-Gloves Sdn. Bhd. C/O Mr. Kenneth J. Stanton President UG Healthcare (USA) Incorporated 2420 Carson Street Suite 125 Torrance, California 90501

Re: K050765

Trade/Device Name: Lano-E, Powder Free, Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 4, 2005 Received: April 5, 2005

Dear Mr. Stanton:

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. Stanton

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/industry/support/index.html.

Sincerely yours,

Quls

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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# Indications for Use

Page - 5

510(k) Number (if known): __K050765

Device Name: Lano-E, Powder Free, Nitrile Examination Gloves

Indications For Use The Lano-E, Powder Free, Nitrile Examination Gloves is a disposable r the Land-E, I owder Froo, Nittio see that is worn on the examiner's hand to prevent contamination between patient and examiner

Prescription Use (Part 21 CFR 801 Subpart D)

: :

.

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AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shiela A. Murphy, MD 4/8/05

insion Sion-Off) Asion of Anesthesiology, General Hospital, Intection Control. Dental Devices

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| Number | 1650/15 |

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