DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR

K033539 · Shen Wei (Usa), Inc. · LYZ · Jan 8, 2004 · General Hospital

Device Facts

• Record ID: K033539
• Device Name: DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
• Applicant: Shen Wei (Usa), Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Jan 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

Device Story

Disposable powder-free vinyl synthetic examination gloves; green color. Worn on examiner's hands during medical examinations. Acts as physical barrier to prevent cross-contamination between patient and examiner. Not intended for chemical protection. Used in clinical settings by healthcare professionals.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable vinyl synthetic material; powder-free; green color. Class I medical device. Standard examination glove form factor.

Indications for Use

Indicated for use by medical examiners to prevent cross-contamination between patient and examiner. Not for use as a chemical barrier.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 8 2004

Ms. Cynthia Liu Service Marketing Manager Shen Wei (USA), Incorporated 2845 Whipple Road Union City, California 94587

Re: K033539

Trade/Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves, Green Color Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: 1 Product Code: LYZ Dated: November 7, 2003 Reccived: November 10, 2003

Dear Ms. Liu

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 approvisions 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 (1 112 ), it insy 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 -Ms. Liu

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 modi that I Dr I may made statutes and regulations administered by other Federal agencies. or the Act of ally I oderal bakers an requirements, including, but not limited to: registration I ou must compry with arrary with and 11 CFR Part 801); good manufacturing practice and listing (21 OF R Parvov), areality systems (QS) regulation (21 CFR Part 820); and if requirements to be form nroduct 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) I mis letter will and it your end finding of substantial equivalence of your device to a premaired 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), n you donte specific at at Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You entired, which and information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Qus

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

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## Koz 3539

Attachment Two

## INDICATION FOR USE

Shen Wei (USA) Inc. Applicant:

Disposable Powder Free Vinyl Synthetic Examination Gloves, Green Color Device Name:

Indication for Use:

A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

This device is not intended to be used as a chemical barrier.

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

Concurrence of CDRH Office of Device Evaluàtion (ODE)

Antoinette Dg. Biler-Berndorf 1-8-64

esthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: K033539

Prescription Use Per 21CFR 801.109 ાર

Over the Counter
(Optional Format 1-2-96)

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