POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE

K021353 · Glormed Intl., Inc. · LYZ · Jun 6, 2002 · General Hospital

Device Facts

• Record ID: K021353
• Device Name: POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE
• Applicant: Glormed Intl., Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Jun 6, 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 patient and examiner.

Device Story

Disposable powder-free poly-vinyl examination gloves; worn on examiner's hand or finger; barrier protection against contamination between patient and examiner; used in hospitals, clinics, laboratories, and doctor/dentist offices; non-sterile; single-use.

Clinical Evidence

Bench testing only. Device met or exceeded ASTM D 5250-00, ASTM D 6124-00, and ASTM D 5151-00 standards. Biocompatibility testing included dermal sensitization and primary skin irritation. Bio-burden testing performed per IEST-RP-CC005-2.

Technological Characteristics

Poly-vinyl material; powder-free; white color; disposable; non-sterile. Complies with ASTM D 5250-00 (Standard Specification for Poly(vinyl chloride) Gloves for Medical Application), ASTM D 6124-00 (Standard Test Method for Residual Powder on Medical Gloves), and ASTM D 5151-00 (Standard Test Method for Detection of Holes in Medical Gloves).

Indications for Use

Indicated for use 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

• Glormed Int'l (K002340)
• Shanghai Poseidon Plastic Products Company, Ltd. (K992979)

Submission Summary (Full Text)

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

6 2002 Jun

## 510(k) SUMMARY

K021353

| Submitted For: | GLORMED INTERNATIONAL, INC. |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | TUCKER & ASSOCIATES<br>Official Correspondent for Glormed International<br>JANNA P. TUCKER, President-CEO<br>198 Avenue de la D'emerald<br>Sparks, NV 89434-9550<br>775-342-2612<br>Phone:<br>Fax:<br>775-342-2613<br>E-Mail:<br>Tuckerjan(@aol.com |
| Date of Submission: | 22 April 2002 |
| Device Name: | POWDER-FREE POLY-VINYL EXAMINATION<br>GLOVES, COLOR: WHITE<br>Class I Device, 80LYZ |
| Proprietary Name: | (Multiple Labels) Powder-Free Poly-Vinyl Exam<br>Gloves, Color: White |
| 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. |
| 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, it<br>is substantially equivalent to the devices manufactured by<br>Glormed Int'l (K002340) and Shanghai Poseidon Plastic<br>Products Company, Ltd. (K992979). |

EXHIBIT L
Page 48 of 49

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

# KO21353

#### 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 5250-00 ASTM D 6124-00 ASTM D 5151-00

Bio-Burden IEST-RP-CC005-2

Bio-Compatibility: Dermal Sensitization Primary Skin Irritation

Conclusion:

This device is substantially equivalent to the devices Approved as K002340 and K9922979.

EXHIBIT L
Page 49 of 49

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the basic outline of the face visible.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021353

Trade/Device Name: Powder-Free Vinyl Examination Gloves, Color White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: April 26, 2002 Received: April 26, 2002

6 2002

JUN

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.

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.

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

Page 2 - Ms. Tucker

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 (OS) 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

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

Enclosure

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

## INDICATIONS FOR USE

16021353

#### APPLICANT:

### GLORMED INTERNATIONAL, INC.

### 510(k) NUMBER:

#### DEVICE NAME:

### POWDER-FREE POLY-VINYL EXAMINATION GLOVES, COLOR: WHITE

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)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Olin S. Lin
(Division Sign-Off)

EXHIBIT B
Page 2 of

nd General Hospital Infection C
i Ojk) Number