TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW

K052636 · Teh Loong Corp. · LYZ · Nov 10, 2005 · General Hospital

Device Facts

• Record ID: K052636
• Device Name: TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
• Applicant: Teh Loong Corp.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthca personnel and patient.

Device Story

Powder-free synthetic vinyl patient examination gloves; intended as a protective barrier for healthcare personnel; worn on hands to prevent cross-contamination between clinician and patient; used in clinical settings; disposable.

Clinical Evidence

Bench testing only.

Technological Characteristics

Synthetic vinyl material; powder-free; patient examination glove; Class I device.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes emanating from its back, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

NOV 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Teh Loong Corporation C/O Mr. Chien Lin 2631, North Magnolia Street Chicago, Illinois 60614

Re: K052636

Trade/Device Name: Powder Free Synthetic Vinyl Patient Examination Gloves, Yellow Regulation Number: Patient Examination Glove Regulation Name: 880.6250 Regulatory Class: I Product Code: LYZ Dated: September 17, 2005 Received: September 26, 2005

Dear Mr. Lin:

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. 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,

Cuts

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

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Image /page/2/Picture/0 description: The image shows a logo with a circle surrounding a triangular shape. Inside the triangle is a design that resembles the letters 'A' and 'Y' connected by a vertical line. In the upper right corner of the circle, there is a circled 'R', which is a registered trademark symbol.

## TEH LOONG CORPORATION

Office : No. 18, Chin Liu St., Shiaukang Dist, Kaohsiung, Taiwan, R.O.C.

Tel : [phone]~8

Fax : [phone]

## ATTACHMENT B

## INDICATION FOR USE STATEMENT

510K Number (if known): .... K 052636 Device Name: Powder Free Synthetic Vinyl Patient Examination Gloves, Yellow

Indications For Use:

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthca personnel and patient.

LONG BEST (XIAMENT) BALL CO., LTD.

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TH CHEN / PRESIDENT

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

.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ................. (Per 21 CFR 801.109)

OR Over-The-Counter Use...X.

My
Sign-Off)

- The-Counter Use ....

Vision Sign-Off)
Mision of Anesthesiology, General Hospital,
Infection Control, Dental Devices (Optional Format

Number: 40524

(Optional Format 1-2-96)