POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)

K040406 · Shun Thai Rubber Gloves Industry Public Co., Ltd. · LYY · May 14, 2004 · General Hospital

Device Facts

• Record ID: K040406
• Device Name: POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
• Applicant: Shun Thai Rubber Gloves Industry Public Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: May 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Disposable latex examination glove; polymer-coated and chlorinated; powder-free. Designed for use by healthcare professionals or individuals to provide a protective barrier on hands/fingers. Prevents cross-contamination between patient and examiner during medical examinations. Features protein labeling of 50 ug/g or less to address latex sensitivity concerns. Used in clinical or home settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Latex. Features: Polymer-coated, chlorinated, powder-free. Protein content: 50 ug/g or less. Form factor: Disposable examination glove.

Indications for Use

Indicated for use as a disposable patient examination glove worn by healthcare examiners to prevent cross-contamination between patient and examiner. Suitable for over-the-counter use.

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 seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three legs.

## MAY 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shun Thai Rubber Gloves Industry Public Company Limited C/O Ms. Janna P. Tucker Official Correspondents Tucker Associates 198 Avenue De La D' emerald Sparks, Nevada 89434-9550

Re: K040406

Trade/Device Name: Polymer Coated Chlorinated, Powder-Free Latex Examination Gloves with Protein Labeling (50 ug/g or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 7, 2004 Received: May 10, 2004

Dear Ms. Tucker:

We have reviewed your Section 510(k) promarket 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 - Ms. Tucker

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. or the Act of all , I outs 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 and insting (2) 21 regulation the quality systems (QS) regulation (21 CFR Part 820); and if requirents as 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 may oveant 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,

Chiu Lin, Ph.D.

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

Enclosure

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

## Indications for Use

## Applicant: SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC COMPANY LIMITED

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

## POLYMER COATED, CHLORINATED Device Name: POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)

Indications For Use: A patient examination glove is a disposable device intended for manuations . or er es that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use x (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kai Mulvey

esthesi

510(k) Number.

Page 1 of ____________________________________________________________________________________________________________________________________________________________________