SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE

K022090 · Syntex Healthcare Products Co., Ltd. · LZA · Sep 3, 2002 · General Hospital

Device Facts

• Record ID: K022090
• Device Name: SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
• Applicant: Syntex Healthcare Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Story

Pre-powdered nitrile examination glove; worn on hands of healthcare personnel; acts as physical barrier to prevent cross-contamination between wearer and patient/environment; used in clinical settings; disposable.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile material; pre-powdered; patient examination glove; Class I device; Product Code LZA.

Indications for Use

Indicated for use by healthcare workers and similar personnel to prevent cross-contamination between the wearer and the patient's body, fluids, waste, or environment.

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 3 2002 SEP

Mr. Tan Swu Choon Deputy General Manager Syntex Healthcare Product Company Limited No. 1, Fanjiazhung Industrial Zone Xinji City, Hebei Province, P.R. CHINA 052360

Re: K022090

Trade/Device Name: Syntex Pre-Powdered Nitrile Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 22, 2002 Received: June 27, 2002

Dear Mr. Choon:

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. Choon

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 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Tim Van Ulven, PhD

Tim 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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## KO22090 510 (k) Number (if known) :

Device Name : Pre-Powdered Nitirile Examination Glove

Indication For Use :

A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

.PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDEDR Concurrence of CDRH. Office of Device Evaluation (ODE)

OR Over The Counter Use Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-95)

Olin S. Ligon

General Hospital

510(k) Number: K022090