POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)

K991422 · Shen Wei (Usa), Inc. · LZA · May 3, 2000 · General Hospital

Device Facts

• Record ID: K991422
• Device Name: POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
• Applicant: Shen Wei (Usa), Inc.
• Product Code: LZA · General Hospital
• Decision Date: May 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder-Free Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) is a powder-free nitrile exam glove for general 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

Powder-free nitrile examination glove; intended for use by healthcare professionals to prevent cross-contamination between patient and examiner. Device functions as a physical barrier; tested for use with chemotherapy drugs. Not intended for use as a chemical barrier. Used in clinical settings; worn on hands.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile material; powder-free; examination glove form factor. Non-sterile.

Indications for Use

Indicated for use as a protective glove worn on the examiner's hand to prevent contamination between patient and examiner in general medical settings.

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

MAY = 3 2000

Mr. Belle Chou General Manager Shen Wei (USA) Incorporated 2845 Whipple Road Union City, California 94587

K991422 Re : Powder-Free Nitrile Examination Glove Trade Name: (Tested for Use with Chemotherapy Drugs) Regulatory Class: I Product Code: LZA March 8, 2000 Dated: March 9, 2000 Received:

Dear Mr. Chou:

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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 requlatory 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

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Page 2 - Mr. Chou

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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" (21 CFR 807.97). Other qeneral 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

Timõ thy A. Ulatows Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K991422

## INDICATION FOR USE

Shen Wei (USA) Inc. Applicant:

Device Name: Powder-Free Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)

Indication For Use:

Powder-Free Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) is a r owdern Tec Nialle Exam Glove (Tocal 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.

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Concurrence of CDRH Office of Device Evaluation (ODE)

SBarrd by Can

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K 991432

Prescription Use Per 21CFR 801.109 OR

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