POWDERED VINYL EXAM GLOVES, WHITE

K030927 · Copioumed Intl., Inc. · LYZ · Apr 17, 2003 · General Hospital

Device Facts

• Record ID: K030927
• Device Name: POWDERED VINYL EXAM GLOVES, WHITE
• Applicant: Copioumed Intl., Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Apr 17, 2003
• 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

Disposable powdered vinyl examination glove; worn on examiner's hand or finger; acts as physical barrier to prevent contamination between patient and examiner; used in clinical settings including doctor offices, dentist offices, laboratories, clinics, and hospitals; intended for use by healthcare professionals.

Clinical Evidence

Bench testing only. Device met or exceeded ASTM D 5250-00E4, ASTM D 5151-99, ASTM D 6124-01, ISO 2859, and MIL Std 105E. Biocompatibility testing included dermal sensitization, primary skin irritation, and bio-burden analysis.

Technological Characteristics

Material: Vinyl with U.S.P. powder. Standards: ASTM D 5250-00E4, ASTM D 5151-99, ASTM D 6124-01, ISO 2859, MIL Std 105E. Non-sterile, disposable, patient examination glove.

Indications for Use

Indicated for use by healthcare professionals in medical settings to prevent cross-contamination between the examiner and the patient.

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

• K021961

Submission Summary (Full Text)

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APR 1 7 2003

| | KO30927 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) SUMMARY | |
| Submitted For: | COPIOUMED INTERNATIONAL, INC. |
| Submitted By: | TUCKER & ASSOCIATES<br>Official Correspondent for COPIOUMED<br>JANNA P. TUCKER, President-CEO<br>198 Avenue de la D'emerald<br>Sparks, NV 89434-9550<br>Phone:<br>775-342-2612<br>Fax:<br>775-342-2613<br>E-Mail:<br>[e-mail] |
| Date of Submission: | 19 March 2003 |
| Device Name: | POWDERED VINYL EXAM GLOVES,<br>WHITE<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. |
| 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 U.S.P.<br>powder, it is the exact same glove manufactured in<br>approved 510(k) K021961. |

EXHIBIT K
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510k) Summary page 2.

## HO30927

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)

Conclusion: Except for the U.S.P. powder, this device is the same glove as approved in K021961.

EXHIBIT K
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APR 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030927

Trade/Device Name: Powdered Vinyl Examination Gloves, White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: March 19, 2003 Received: March 24, 2003

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.

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#### 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 vours.

Susan Runres

Susan Runner, DDS, MA Interim 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

#### COPIOUMED INTERNATIONAL, INC. APPLICANT:

#### 510(k) NUMBER: - Ko30927

### POWDERED VINYL EXAM GLOVES, DEVICE NAME: 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_\$\checkmark\$

(Optional Format 1-2-96)

Olen Slim

sthesiology, General Hospital

510(k) Number: K030927

EXHIBIT B
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