UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES

K013163 · N.S. Uni-Gloves Sdn. Bhd. · LYY · Jan 22, 2002 · General Hospital

Device Facts

• Record ID: K013163
• Device Name: UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
• Applicant: N.S. Uni-Gloves Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jan 22, 2002
• 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

UniGlove Lano-E is a powder-free latex examination glove; processed with pharmaceutical-grade lanolin and Vitamin E as emollient/conditioning agents. Worn by healthcare examiners to provide a barrier against contamination between patient and examiner. Device is disposable; features beaded cuff; meets ASTM D3578-00 standards for physical properties and water-tightness. Provides protection during clinical examinations.

Clinical Evidence

Bench testing only. Device meets ASTM D3578-00, EN 455-1/2, and ISO 2859-1 standards. Physical property testing (tensile strength, ultimate elongation) performed before and after aging. Water-tightness testing (1000ml) performed to verify barrier integrity.

Technological Characteristics

Material: Latex. Beaded cuff. Powder residue: max 2mg/glove. Dimensions: 240mm length, 95mm width (medium). Thickness: 0.15-0.20mm (palm), 0.17-0.25mm (finger), 0.10-0.15mm (cuff). Tensile strength: 21 MPa (before aging), 16 MPa (after). Ultimate elongation: 700% (before), 500% (after). Contains lanolin and Vitamin E. Complies with ASTM D3578-00, EN 455-1/2, ISO 2859-1.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-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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Image /page/0/Picture/0 description: The image shows the logo for "UC Healthcare (USA) Inc.". The logo consists of the letters "UC" stacked on top of each other on the left side of the image. To the right of the letters is the text "Healthcare (USA) Inc."

2420 Carson Street · Suite 125 · Torrance, CA 90501

Local: 310-328-7981 Toll Free: 800-328-7981 Fax: [phone]

# JAN 2 2 2002

#### SUMMARY PREMARKET 510(k) NOTIFICATION For UniGlove Lano-E Powder-Free Latex Examination Gloves 510(k) Number: Kol3163

#### 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

Registration No. 8040880 Devise Listing No. B 034616 510(k) Number:

#### Official Correspondent in the United States:

Robert D. Vander Leek, President UG Healthcare (USA) Inc. 2420 Carson St., Suite 125 Torrance, CA 90501

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

#### Submitted: September 14, 2001

#### A. Description of the Device

Trade Name: UniGlove Lano-E Powder-Free Latex Examination Glove Common Name: Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I Powder-Free Latex examination glove 80LYY that meets all the of requirements of ASTM Standard D 3578 - 00

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.

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## SUMMARY PREMARKET 510(k) NOTIFICATION For UniGlove Lano-E Powder-Free Latex Examination Gloves 510(k) Number:

September 14, 2001

#### Summary of Technological Characteristics:

Material: Latex Cuff: Beaded Powder Residue: Maximum 2mg/glove Quality Assurance: In compliance with ASTM D3578-00, EN 455-2 : 1995, EN 455-1 : 1993, ISO 2859-1:1989 and manufactured under GMP.

#### 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: | 0.15 to 0.20 mm (at center of palm) |
| Finger Thickness: | 0.17 to 0.25 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

| | BEFORE AGING |
|----------------------|-----------------|
| Tensile Strength: | 21. Mpa minimum |
| Ultimate Elongation: | 700% minimum |
| Pinhole AQL | 1.5 minimum |

16.0 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

Conclusion: The UniGlove Powder-Free Latex Examination Glove meets the physical property requirements of ASTM D 3578-00 and the FDA 1000 ml water test both before and after aging.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. 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

## JAN 2 2 2002

N.S. Uni-Gloves Sdn. Bhd. C/O Robert D. Vander Leek UG Healthcare (USA), Incorporated 2420 Carson Street, Suite 125 Torrence, California 90501

Re: K013163

Trade/Device Name: UniGlove Lano-E Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 8, 2002 Received: January 9, 2002

Dear Mr. Leek:

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 Amendie entiments, 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 approvisions 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 (1 Mr.), it nay ob days 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. Leek

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,

L. Alatort

Timothy latowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_KO13163

UNIGLOVE LANO-E POWDER-FREE EXAMINATION GLOVES Device Name:_ WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

Indications For 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 patient and examiner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use_ (Per 21 CFR 801.109) (Optional Format 1-2-96)

Chin S. Lin

Civision Sign-Off) vision of Dental, Infection Control, i Ceneral Hospita i; Number