NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES

K974223 · Derlin Company , Ltd. · LZA · Dec 18, 1997 · General Hospital

Device Facts

• Record ID: K974223
• Device Name: NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES
• Applicant: Derlin Company , Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Device Story

Nitrile powder-free patient examination gloves; intended as protective barrier for healthcare personnel; worn on hands to prevent cross-contamination between clinician and patient; used in clinical settings; disposable.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nitrile material; powder-free; patient examination glove; Class I device; Product Code LZA.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hands to prevent cross-contamination between the personnel 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.

Submission Summary (Full Text)

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

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling a bird in flight, composed of three curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 18 1997

Derlin Company Ltd. C/O Mr. John Bucher Official U.S. Correspondent 1601 Henry Place Waukegan, Illinois 60085

Re : K974223 Nitrile Powder Free Patient Examination Trade Name: Gloves Requlatory Class: I Product Code: LZA October 8, 1997 Dated: Received: November 12, 1997

Dear Mr. Bucher:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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

Page 2 - Mr. Bucher

through 542 of the Act for devices under the Electronic chrough Sra or on notrol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predication of mits 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compreates as (advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regaration Chorifical (21 CFR 807.97) -Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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

## Attachmet I

## Indication For Use Statement

K914223 510k Number (if known):_ Device Name: Nitrile Powder Free Patient Examination Gloves Indications For Use:

A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

**DERLIN CO.,LTD**

## Gily S. Peri

EDDY D LIOU

(Per 21 CFR 801.109)

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

| <i>Division Sign-Off</i> | |
|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Division of Dental, Infection Control and General Hospital Devices, Office of Device Evaluation (ODE) | |
| 510(k) Number | K974223 |
| Prescription Use | OR Over-The-Counter Use <span style="text-decoration: underline;">X</span> |

(Optional Format 1-2-96)