OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)

K993479 · Omnigrace (Thailand) , Ltd. · LYY · Nov 19, 1999 · General Hospital

Device Facts

• Record ID: K993479
• Device Name: OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)
• Applicant: Omnigrace (Thailand) , 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

Latex examination glove; powdered; features protein content claim of 100 micrograms or less. Worn on hands by healthcare personnel; acts as physical barrier to prevent contamination between wearer and patient. Used in clinical settings. Benefits patient and provider by reducing risk of cross-contamination.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex examination glove; powdered; protein content claim ≤ 100 micrograms.

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 Requlatory Affairs For OmniGrace (Thailand) Ltd. 7815 Vanderbilt Drive NW North Canton, Ohio 44720

K993479 Re : OmniGrace Latex Examination Glove Powdered, Trade Name: with Protein Claim (100 Micrograms Or Less) Requlatory Class: I Product Code: LYY Dated: October 13, 1999 Received: October 14, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੈ 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 regulation 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 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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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, Powdered, with Protein Claim (100 Micrograms or Less)

## INDICATIONS FOR USE STATEMENT

Applicant : OmniGrace (Thailand) Ltd. 510(k) Number : K 993479 Device Name : OmniGrace Latex Examination Glove, Powdered, with Protein Claim (100 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)

Prescription Use Per 21 CFR 801.109 OR Over-The-Counter

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(Division Sign-Off) Division of Dental, Infection Contro and General Hospita 510(k) Number .