OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED

K993050 · Omnigrace , Ltd. · LZA · Nov 9, 1999 · General Hospital

Device Facts

• Record ID: K993050
• Device Name: OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
• Applicant: Omnigrace , Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Nitrile patient examination glove; green color; powder-free; polymer-coated. Used by healthcare personnel to provide a protective barrier on the hands. Prevents cross-contamination between patient and clinician during examinations. Device is a disposable, non-sterile physical barrier.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nitrile material; powder-free; polymer-coated; disposable; non-sterile; form factor is a hand-worn glove.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the wearer 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 1995

Mr. William E. Patton Vice President Regulatory Affairs Omnigrace (Thailand) Ltd. 7815 Vanderbilt Drive NW North Canton, Ohio 44720

Re : K993050 Omnigrace Patient Examination Glove, Trade Name: Nitrile, Green, Powder-Free, Polymer Coated Regulatory Class: I Product Code: LZA September 10, 1999 Dated: Received: September 10, 1999

Dear Mr. Patton:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Patton

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberizon in four for 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 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 che regulation chercreda, "hibblanding by other general 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.fda.gov/cdrh/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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K993050

OMNIGRACE (THAILAND) LTD. 641 MOO 5 KANCHANAWANIT ROAD TAMBON BANPRU HATYAI SONGKHLA THAILAND 90250 TEL: [phone] FAX: [phone]

> September 1999 Attachment II

## OmniGrace (Thailand) Ltd. 510(k) Premarket Notification Patient Examination Glove, Nitrile, Green, Powder-Free, Polymer Coated

## INDICATIONS FOR USE STATEMENT

Applicant: OmniGrace (Thailand) Ltd. 510(k) Number: Device Name: OmniGrace Nitrile, Green, Examination Glove, Powder Free, Polymer Coated.

## Indications For Use

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Olin S. him

n Sian-Off of Dental, Infection Control, ral Hospita mber

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OR

Prescription Use Per 21 CFR 801.109 Over-The-Counter

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