POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE

K021961 · Copioumed Intl., Inc. · LYZ · Jul 2, 2002 · General Hospital

Device Facts

• Record ID: K021961
• Device Name: POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
• Applicant: Copioumed Intl., Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 2, 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 poly-vinyl examination glove; worn on hand or finger by healthcare professionals in clinics, hospitals, and laboratories. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Device is non-sterile and powder-free. Benefit is infection control during routine medical examinations.

Clinical Evidence

Bench testing only. Device met or exceeded ASTM D 5250-00, ASTM D 5151-00, and ASTM D 6124-00 standards. Biocompatibility testing included dermal sensitization and primary skin irritation. No clinical data presented.

Technological Characteristics

Material: Poly-vinyl. Form factor: Disposable examination glove. Standards: ASTM D 5250-00 (standard specification for poly(vinyl chloride) gloves), ASTM D 5151-00 (test for freedom from holes), ASTM D 6124-00 (test for residual powder).

Indications for Use

Indicated for use as a disposable patient examination glove worn by healthcare professionals on the 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.

Predicate Devices

• Shanghai Poseidon Plastic Products Company Limited (K992979)
• Glormed International (K002340)

Submission Summary (Full Text)

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JUL = 2 2002

## Ko21961

## 510(k) SUMMARY

| Submitted For: | COPIOUMED INTERNATIONAL, INC.<br>6f-1, No. 169-12, Sec. 2<br>Chang AN East Road<br>Taipei, Taiwan, ROC |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | TUCKER & ASSOCIATES<br>Official Correspondent for Copioumed International, 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: | 10 June 2002 |
| Device Name: | POWDER-FREE POLY-VINYL EXAM GLOVES,<br>COLOR: WHITE<br>Class I Device, 80LZA |
| Proprietary Name: | (Multiple Labels) Powder-Free Poly-Vinyl Exam Gloves,<br>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<br>by Shanghai Poseidon Plastic Products Company Limited,<br>(K992979) and Glormed International (K002340) |

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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 5151-00 ASTM D 6124-00 Bio-Burden

Bio-Compatibility: Dermal Sensitization Primary Skin Irritation

Conclusion:

Except for color, this device is substantially equivalent to the devices approved as K992979 and K002340

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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 features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of an eagle with three profiles, suggesting a focus on people and health.

JUL = 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021961

Trade/Device Name: Powder-Free Poly-Vinyl Examination Gloves, White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: June 10, 2002 Received: June 14, 2002

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.

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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 (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.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

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## INDICATIONS FOR USE

## COPIOUMED INTERNATIONAL, INC. APPLICANT: K021961 510(k) NUMBER: POWDER-FREE POLY-VINYL DEVICE NAME: 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)

Qlin S. Lim

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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .