POWDER-FREE BLUE VINYL EXAM GLOVES

K041945 · Glormed Intl., Inc. · LYZ · Aug 20, 2004 · General Hospital

Device Facts

• Record ID: K041945
• Device Name: POWDER-FREE BLUE VINYL EXAM GLOVES
• Applicant: Glormed Intl., Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Aug 20, 2004
• 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 patient and examiner.

Device Story

Powder-free blue vinyl exam gloves; disposable; worn on hands/fingers by healthcare professionals (dentists, doctors, clinic/hospital staff) during patient examinations. Function as physical barrier to prevent cross-contamination between patient and examiner. Device is non-sterile, single-use. Benefits include protection of both patient and clinician from potential contaminants during routine medical procedures.

Clinical Evidence

Bench testing only. Device met or exceeded ASTM D 5250-00E4, ASTM D 5151-99, and ASTM D 6124-01 standards. Biocompatibility testing included dermal sensitization, primary skin irritation, and bio-burden (Procedure Method 8315).

Technological Characteristics

Vinyl material; powder-free; blue color. Standards: ASTM D 5250-00E4 (physical properties), ASTM D 5151-99 (leak test), ASTM D 6124-01 (residual powder), ISO 2859, MIL Std 105E. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove by healthcare professionals in medical settings 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.

Predicate Devices

• K002340
• K021353

Submission Summary (Full Text)

{0}------------------------------------------------

K041945

## AUG 2 0 2004

## 510(k) SUMMARY

| Submitted For: | GLORMED INTERNATIONAL, INC. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | TUCKER & ASSOCIATES<br>Official Correspondent for GLORMED INT'L., INC.<br>JANNA P. TUCKER, President-CEO<br>198 Avenue de la D'emerald<br>Sparks, NV 89434-9550 |
| Phone: | 775-342-2612 |
| Fax: | 775-342-2613 |
| E-Mail: | [e-mail] |
| Date of Submission: | 14 July 2004 |
| Device Name: | POWDER-FREE BLUE VINYL EXAM GLOVES<br>Class I Device, 80LYZ |
| Proprietary Name: | (Multiple Private Labels) |
| Labels/Labeling: | This device will be marketed to healthcare professionals at<br>Dentist and Doctor Offices, Laboratories, Clinics and<br>Hospitals through its distributors for the intended use of |
| exam | gloves. |
| Intended Use: | A patient examination glove is a disposable device intended<br>for medical purposes that is worn on the examiner's hand<br>or finger to prevent contamination between patient and<br>examiner. |
| Substantial Equivalence: | Both in its intended use and/or physical<br>characteristics, this device is equivalent to devices<br>currently marketed by U.S. companies. Except for color,<br>these<br>gloves are comparable to gloves approved as K002340 and<br>K021353 |

EXHIBIT L
Page 48 of 49

{1}------------------------------------------------

510k) Summary page 2.

Test Results (Means and/or Successful Results:

This device has met or exceeded the following standards and/or tests:

ASTM D 5250-00E4 ASTM D 5151-99 ASTM D 6124-01 ISO 2859 MIL Std 105E Bio-Compatibility: Dermal Sensitization Primary Skin Irritation Bio-Burden (Procedure Method 8315)

Except for color, this device is comparable to gloves approved in Conclusion: K002340 and K021353.

EXHIBIT L
Page 49 of 49

{2}------------------------------------------------

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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

AUG 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Glormed International, Incorporated C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' Emerald Sparks. Nevada 89434-9550

Re: K041945

Trade/Device Name: Powder-Free Blue Vinyl Exam Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 14, 2004 Received: July 20, 2004

Dear Ms. Tucker:

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.

{3}------------------------------------------------

Page 2 - Ms. Tucker

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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

hiu 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

{4}------------------------------------------------

### INDICATIONS FOR USE

# APPLICANT: GLORMED INTERNATIONAL, INC.

510(k) NUMBER: K041945

#### POWDER-FREE BLUE VINYL EXAM DEVICE NAME: GLOVES

A patient examination glove is a disposable device intended for medical purposes that is A patient examination glove is a disposuole do not ansamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Muly

General Hospital,

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number: K041945