OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE

K980419 · Omnigrace (Thailand) , Ltd. · LZA · Mar 13, 1998 · General Hospital

Device Facts

• Record ID: K980419
• Device Name: OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE
• Applicant: Omnigrace (Thailand) , Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 13, 1998
• 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

The Omni Flex Nitrile Examination Glove is a powder-free, green-colored medical glove. It functions as a protective barrier worn on the hands of healthcare or similar personnel. Its primary purpose is to prevent cross-contamination between the wearer and the patient during medical examinations or procedures. It is a single-use, disposable device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nitrile rubber material; powder-free; green color; disposable; Class I medical device.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 13 1998

OmniGrace (Thailand) Ltd. ·C/O William E. Patton Vice President Regulatory Affairs 7815 Vanderbilt Drive NW North Canton, Ohio 44720

Re : K980419 Omni Flex Nitrile Examination Glove, Trade Name: Powder Free, "Green" Regulatory Class: I Product Code: LZA January 23, 1998 Dated: February 3, 1998 Received:

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, Druq, and Cosmetic Act (Act). 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, qood 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to-895. A ... ....................................................................................................................... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to 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

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## Page 2 - Mr. Patton

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic enrough Siz of Control 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 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 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" (21 CFR 807.97). 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.fdfa.gov/cdrh/dsmamain.html".

Sincerely yours,

Timofei A. Ulatowski

Timot My 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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K980419

FAX: [phone]

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March 7, 1998 Attachment II Revised

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

## INDICATIONS FOR USE STATEMENT

Applicant : OmniGrace (Thailand) Ltd. 510(k) Number: K980419 STO(K) Number : 1 - 1 0 / 5 Nitrile Examination Glove, Powder Free, Green

## 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.

Chiu S. Lin

(Division Sign-Off Division of Dental, Infectio and General Hospit 5 1 O(k) Number

Over the Counter

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OMNIGRACE (THAILAND) LTD. 841 MOO5 KANCHANAWANIT ROAD TAMBON BANPRU HATYAI SONGKHLA THAILAND 90250