OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM

K012402 · Omnigrace (Thailand) , Ltd. · LYY · Oct 12, 2001 · General Hospital

Device Facts

• Record ID: K012402
• Device Name: OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM
• Applicant: Omnigrace (Thailand) , Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Oct 12, 2001
• 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

The OmniGrace Latex Examination Glove is a powder-free, polymer-coated latex glove designed for use by healthcare and similar personnel. It functions as a physical barrier worn on the hands to prevent cross-contamination between the healthcare provider and the patient. The device is intended for use in clinical or similar settings where infection control is required. It provides protection through its material properties as a disposable examination glove.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex material, powder-free, polymer-coated. Class I medical device, product code LYY. Standard examination glove form factor.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hands 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2001

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

Re: K012402

Trade/Device Name: Omni Grace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: July 27, 2001 Received: July 27, 2001

Dear Mr. Patton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Patton

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements modi that I Dri mas mass statutes and regulations administered by other Federal agencies. or the Act of ally I oderal tunates requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 CF result in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as set form in als quadis ion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 110(k) premarket notification. The FDA finding of substantial equivalence of your device to 310(k) promation noticate 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Richard

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

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

> July 2001 Attachment II

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

## INDICATIONS FOR USE STATEMENT

Applicant : OmniGrace (Thailand) Ltd. 510(k) Number : KO12402 Device Name : OmniGrace Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim

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 | OR | Over-The-Counter |
|--------------------|----|------------------|
| Per 21 CFR 801.109 | | |

(5)

(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

| 510(k) Number | |
|---------------|--|
|---------------|--|