OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE

K983730 · Omnigrace , Ltd. · LZA · Dec 11, 1998 · General Hospital

Device Facts

• Record ID: K983730
• Device Name: OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE
• Applicant: Omnigrace , Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 11, 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 / moundal you between health care personnel and the patient.

Device Story

Omni Flex Nitrile Examination Glove is a powder-free, blue nitrile glove. Used by healthcare personnel as a protective barrier to prevent cross-contamination between the wearer and the patient. Device functions as a physical barrier; no electronic or mechanical components. Used in clinical or similar settings. Benefits include protection against potential contaminants during patient examinations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nitrile material; powder-free; blue color; patient examination glove form factor. No energy source or software.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier between the user 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

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

K983730 Re : Omni Flex Nitrile Examination Glove, Trade Name: Powdered-Free, Blue Requlatory Class: I Product Code: LZA October 19, 1998 Dated: Received: October 22, 1998

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 regulation (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 Product Radiation 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 requlation (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" (21CFR 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.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Patricia Ciconti Hor

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

Enclosure

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641 MOO 5 KANCHANAWANIT ROAD TAMBON BANPRU HATYAI SONGKHLA THAILAND 90250 TEL [phone] FAX: [phone]

> October 19, 1998 Attachment II

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

## INDICATIONS FOR USE STATEMENT

Applicant : OmniGrace (Thailand) Ltd. 510(k) Number : K983730 510(K) Namber . (CTC 5 / Do
Device Name :Omni Flex Nitrile Examination Glove, Powder Free, Blue

Indications For Use

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

(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 X

Qisa Solaiz

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number: K983730