POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM

K062688 · Ug Healthcare (Usa), Inc. · LYY · Nov 30, 2006 · General Hospital

Device Facts

• Record ID: K062688
• Device Name: POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
• Applicant: Ug Healthcare (Usa), Inc.
• Product Code: LYY · General Hospital
• Decision Date: Nov 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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 the patient and the examiner.

Device Story

Powder-free black latex examination glove; disposable; worn on examiner's hand. Prevents contamination between patient and examiner. Manufactured from latex; features beaded cuff; black colorant added. Meets ASTM D3578-05 standards for physical properties and water-tight testing. Protein content labeled at <50ug/g. Used in clinical settings by healthcare providers.

Clinical Evidence

Bench testing only. Device evaluated against ASTM D3578-05 standards for physical properties (tensile strength, elongation), dimensions, and water-tight integrity (1000ml test) before and after aging. Protein content verified at <50ug/g.

Technological Characteristics

Material: Latex. Design: Powder-free, beaded cuff. Dimensions: 240mm length, 0.13-0.18mm palm thickness. Standards: ASTM D3578-05, ISO9001:2000. Physical properties: 21.0 MPa tensile strength (before aging), 700% elongation (before aging). Protein level: <50ug/g.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Includes a protein labeling claim of 50 micrograms or less total water extractable protein per gram of glove.

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

• Latex Powder-Free Examination Gloves

Submission Summary (Full Text)

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## Submission Applicant/Official Correspondent

Kenneth J. Stanton,President UG Healthcare (USA) Inc. 2420 Carson Street, Suite 125 Torrance, California 90501 USA Tel: [phone] Fax: [phone]

NOV 3 U 2006

Registration No. 2087418 Device Listing No. E408504

510(k) Number:

Submitted: September 7, 2006

#### A. Description of the Device

Trade Name: Powder-Free Black Latex Examination Glove With Protein Labeling Claim

Common Name: Examination Gloves

Classification Name: Patient Examination Glove (per 21 CFR 880.6251)

Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-05.

Predicative Devices: Latex Powder-Free Examination Gloves

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 Powder-Free Black Latex Examination Glove With Protein Labeling Claim 510(k) Number: K 062688

> > Page - 9

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# Summary of Technological Characteristics:

Powder Residue: Maximum 2mg/glove Cuff: Beaded Material: Latex Material. Latex Quality ASSurancer 11: Com859-1:1999 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: | 0.13 to 0.18mm (at center of palm) |
| Finger Thickness: | 0.15 to 0.20 mm (at 15mm from tip of center finger) |
| Cuff Thickness: | 0.10 to 0.15 mm (at 40mm from the beaded end) |

## BEFORE AGING

| Tensile Strength: | 21.0 Mpa minimum |
|----------------------|------------------|
| Ultimate Elongation: | 700% minimum |
| Pinhole AQL | 1.5 minimum |

AFTER AGING 16.0 Mpa minimum 500% minimum 1.5 minimum

## Special Properties:_Black Colorant

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

Sizes: XXS — XXL

Conclusion: The Powder-Free Black Latex Examination Glove With Profein Labeling Claim meets the physical property requirements of ASTM D 3578-05, the FDA 1000 ml water test both before and after aging, and the Protein Labeling Claim Level at <50ug/g.

> Page - 10 SUMMARY PREMARKET 510(k) NOTIFICATION Powder-Free Black Latex Examination Glove With Protein Labeling Claim

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kenneth J. Stanton President UG Healthcare (USA), Incorporated 2420 Carson Street, Suite 125 Torrance, California 90501-3163

NOV 3 U 2006

Re: K062688

Trade/Device Name: Powder-Free Black Latex Examination Glove with Protein Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: II Product Code: LYY Dated: November 8, 2006 Received: November 15, 2006

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 I least that FDA has made a determination that your device complies with other requirements moun mat 1 DT mas may Federal statutes and regulations administered by other Federal agencies. of the Act of any I oucture the Act's requirements, including, but not limited to: registration r out must comply with and are reseling (21 CFR Part 801); good manufacturing practice and and listing (21 OF R Part 067), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as bet form inroduct 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) Fins fetter wifi and in J . The FDA finding of substantial equivalence of your device to a premitser notified on. - The Pice 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), n free 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,

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

#### 510(k) Number (if known): K062688

Device Name: Powder-Free Black Latex Examination Glove with Protein

Labeling Claim.

Indications for Use: The Powder-Free Black Examination Glove with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

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)

Shula A. Murphy, MD

ion of Anesthesiology, General Hospital,
..con Control, Dental Devices

Number: K062188

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