SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE

K982416 · Shun Thai Rubber Gloves Industry Co., Ltd. · LYY · Nov 24, 1998 · General Hospital

Device Facts

• Record ID: K982416
• Device Name: SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
• Applicant: Shun Thai Rubber Gloves Industry Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Nov 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove is worn on the hand(s) of health care and similar personnel To prevent contamination between heatlh care personnel and the patient.

Device Story

Latex examination glove; powder-free; worn on hands by healthcare personnel; serves as physical barrier to prevent cross-contamination between wearer and patient; used in clinical settings; provides protection during patient examinations.

Clinical Evidence

No clinical data provided; bench testing only regarding protein content and physical properties.

Technological Characteristics

Latex material; powder-free; protein content limited to 50 mcgm or less per gram; Class I medical 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 Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with wavy lines below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 24 1998

Shun Thai Rubber Gloves Company, Limited C/O William Lowenkamp Jr., Ph.D. Lowenkamp International P.O. Box 878, Lowenkamp Lane Hazlehurst, Mississippi 39083

K982416 Re : Shun-Thai - "Safe-Contact", Boston Medical Trade Name: Latex Exam Gloves 50 mcgm or Less of Total Water Extractable Protein Per Gram Requlatory Class: I LYY Product Code: Dated: October 31, 1998 Received: November 3, 1998

Dear Dr. Lowenkamp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Dr. Lowenkamp

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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K982416

## INDICATIONS FOR USE

## SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. Applicant:

510(k) Number (if known): NEW FILING

Device Name: LATEX EXAMINATION GLOVE, POWDER-FREE ,

Indications for Use: "A medical glove is worn on the hand(s) of health care and similar personnel To prevent contamination between heatlh care personnel and the patient."

## DO NOT WRITE BELOW THIS LINE - (FOR FDA USE ONLY)

Concurrence of CDRH Office of Device Evaluation (ODE)

Clin S. Lin
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital D 510(k) Number

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter

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