POWDERED LATEX EXAMINATION GLOVES

K013026 · Great Glove (Thailand) Co. , Ltd. · LYY · Oct 15, 2001 · General Hospital

Device Facts

• Record ID: K013026
• Device Name: POWDERED LATEX EXAMINATION GLOVES
• Applicant: Great Glove (Thailand) Co. , Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Oct 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powdered Latex Examination Gloves are worn on the hands of health care and Formilar personnel to prevent contamination between health care personnel and the patient.

Device Story

Powdered latex examination gloves; worn on hands by healthcare and similar personnel; barrier protection to prevent contamination between wearer and patient; non-sterile, disposable; intended for over-the-counter use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Latex; Form factor: Examination glove; Feature: Powdered; Class I device; Regulation 880.6250.

Indications for Use

Indicated for use by health care and similar personnel 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

OCT 1 5 2001

Mr. KM Lee General Manager Great Glove (Thailand) Company Limited 180/3 M. 7 Srisonthon Road T. Srisonthon, A. Thalang, Phuket THAILAND

Re: K013026

Trade/Device Name: Powdered Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: September 6, 2001 Received: September 10, 2001

Dear Mr. Lee:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not

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mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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 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 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,

Susan Runyon

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

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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The Information, data and labeling claims in the 510(k) submission must support and agree with the Indications for Use statement.

INDICATIONS FOR USE

| Applicant: | GREAT GLOVE (THAILAND) CO. LTD. |
|---------------------------|-----------------------------------|
| 510(k) Number (If known): | K013026 |
| Device Name: | POWDERED LATEX EXAMINATION GLOVES |

## Indications For Use:

Powdered Latex Examination Gloves are worn on the hands of health care and Formilar personnel to prevent contamination between health care personnel and the patient.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Ollice of Device Evaluation (ODE)

Chris S. Lin

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

Prescription Use Per 21 CPR 801.109 ાર

Over-the-Counter X

(Optional Pormat 1-2-96)

· For a new submission, do NOT fill in the 510(k) number blank.