OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE

K990701 · Omnigrace (Thailand) , Ltd. · LZA · May 5, 1999 · General Hospital

Device Facts

• Record ID: K990701
• Device Name: OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE
• Applicant: Omnigrace (Thailand) , Ltd.
• Product Code: LZA · General Hospital
• Decision Date: May 5, 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

The Omni Nitrile Flex Examination Glove is a powder-free, purple nitrile glove designed for use by healthcare personnel. It functions as a physical barrier worn on the hands to prevent cross-contamination between the clinician and the patient. The device is intended for use in clinical or similar settings where infection control is required. It is a single-use, disposable protective item.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nitrile material; powder-free; purple color; patient examination glove; disposable; non-sterile.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, formed by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1999 MAY

Mr. William E. Patton Vice President Regulatory Affairs OmniGrace (Thailand) Ltd. 641 Moo 5 Kanchanawanit Road Tambon Banpru, HatYai, Songkhla THAILAND 90250

K990701 Re : Trade Name: Omni Nitrile Flex Examination Glove, Powder-Free, Purple Requlatory Class: I Product Code: LZA February 27, 1999 Dated: Received: March 3, 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 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). 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug 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 not affect any obligation you might have under sections 531

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Page 2 - Mr. Patton

through 542 of the Act for devices under the Electronic Enrough 542 Of the Act 101 actions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as Inis leccer will arrow your market notification. The FDA described in your 510 m. privalence of your device to a legally marketed predicate device results in a classification for your marketed predicate device to proceed to the market.

If you desire specific advice for your device on our labeling II you debire bpoor and additionally 809.10 for in regulation (ir elevices), please contact the Office of vitro diagnoscic devices// proade of one of the questions on Compilance at (301) see tising of your device, please contact the promocion and advorozes on 1301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your be Division of Small Manufacturers Assistance obtained from the biving [phone] or [phone] or at its internet address

ites fileeries aaasov/cdrh/dsma/dsmamajn.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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K990701

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

> February 1999 Attachment II

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

## INDICATIONS FOR USE STATEMENT

Applicant : OmniGrace (Thailand) Ltd. 510(k) Number : Device Name :Omni Flex Nitrile Examination Glove, Powder Free, Purple

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)

Prescription Use per 21CFR 801.109 ___________________________________________________________________________________________________________________________________________

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Qian S. Lin
Division Sign. Off.

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