OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)

K993419 · Omnigrace , Ltd. · LYY · Nov 19, 1999 · General Hospital

Device Facts

• Record ID: K993419
• Device Name: OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)
• Applicant: Omnigrace , Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Nov 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

OmniGrace Latex Examination Glove is a powder-free, polymer-coated medical glove. Designed for use by healthcare and similar personnel to serve as a protective barrier, the glove is worn on the hands to prevent cross-contamination between the wearer and the patient. It is a single-use, non-sterile device intended for general examination environments.

Clinical Evidence

No clinical data provided; device relies on established material properties for latex examination gloves.

Technological Characteristics

Latex examination glove, powder-free, polymer-coated. Protein content labeled at 50 micrograms or less. Class I device, product code LYY.

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 1 9 1999

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

K993419 Re : OmniGrace Latex Examination Glove, Powder-Trade Name: Free: Polymer Coated with Protein Labeling Claim [50 Microgram or Less] Regulatory Class: I Product Code: LYY October 8, 1999 Dated: Received: October 12, 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, Druq, 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, labelinq, 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) requlation (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 the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Patton

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 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy R. White, President

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

Enclosure

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

> October 1999 Attachment II

## OmniGrace (Thailand) Ltd. 510(k) Premarket Notification Patient Examination Glove, Latex, Powder-Free, Polymer Coated, with Protein Claim (50 Micrograms or Less)

## INDICATIONS FOR USE STATEMENT

Applicant : OmniGrace (Thailand) Ltd. 510(k) Number : K 993419 Device Name :OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim (50 Micrograms or Less)

## 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)

OR

Prescription Use Per 21 CFR 801.109 Over-The-Counter

e-Counter

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