TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE

K052634 · Teh Loong Corp. · LYZ · Oct 11, 2005 · General Hospital

Device Facts

• Record ID: K052634
• Device Name: TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
• Applicant: Teh Loong Corp.
• Product Code: LYZ · General Hospital
• Decision Date: Oct 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove is wom on the hand of healtheare and similar personnel to prevent contantination between healtheare personnel and patient.

Device Story

Powdered synthetic vinyl patient examination glove; worn on hands by healthcare personnel; acts as protective barrier to prevent cross-contamination between patient and provider; intended for general examination use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic vinyl material; powdered; patient examination glove; Class I device; 21 CFR 880.6250; product code LYZ.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hands to prevent contamination between the personnel 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a group of people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2005

Mr. Chien Lin TEH Loong Corporation 2631 N. Magnolia Street Chicago, Illinois 60614

Re: K052634

Trade/Device Name: TEH Loong Powdered Synthetic Vinyl Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: September 17, 2005 Received: September 26, 2005

Dear Mr. Lin:

This letter corrects our substantially equivalent letter of October 11, 2005.

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.

{1}------------------------------------------------

Page 2 - Mr. Lin

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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

Syette Y. Michael md.

Chia Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## INDICATION FOR USE STATEN

510K Number (if known): K052634

Device Name: Powdered Synthetic Vinyl Patient Examination Gloves, White

Indications For Use:

A medical glove is wom on the hand of healtheare and similar personnel to prevent contantination between healtheare personnel and patient.

LONG BEST (XIAMENT) BALL CO , LTD

T. H. Cila

TH Chen/PRESIDENT

Prescription Use (Part 21 CFR 801 Subper: 1 - AND/OR

Over-The-Counter Use (?1 CFR 801 Subpart C)

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

Copic cremee of CDRH, Office of Device Evaluation (ODE)

Shule R. Murphy D/inks

eneral Hospital Division of Anesthestolo Infection Control, Der

510(k) Number: