POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)

K032024 · Shen Wei (Usa), Inc. · LZA · Oct 29, 2003 · General Hospital

Device Facts

• Record ID: K032024
• Device Name: POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
• Applicant: Shen Wei (Usa), Inc.
• Product Code: LZA · General Hospital
• Decision Date: Oct 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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

Textured powder-free nitrile examination glove; blue color. Device worn on examiner's hand to provide barrier protection against contamination between patient and examiner. Tested for use with chemotherapy drugs. Used in clinical settings by healthcare personnel. Provides physical barrier; does not function as chemical barrier.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Nitrile material; powder-free; textured surface; blue color. Patient examination glove (21 CFR 880.6250).

Indications for Use

Indicated for use as a patient examination glove to prevent cross-contamination between patient and examiner. Intended for use by healthcare professionals. 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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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2003

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

Re: K032024

Trade/Device Name: Textured Powder-Free Nitrile Examination Glove, Blue Color Tested for Use with Chemotherapy Drug Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 14, 2003 Received: October 16, 2003

Dear Ms. Chou:

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 - Ms. Chou

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), 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 Division 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.

Qulz
Shia Liu, 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

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## Attachment Two

### INDICATION FOR USE

Shen Wei (USA) Inc. Applicant:

K 032024

Device Name: Textured Powder-Free Nitrile Examination Gloves , Blue Color, Tested for Use with Chemotherapy Drugs

#### 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 Evaluation (ODE)

Pat. Atty. Siterin. Fairchild Inc., 10/30/86

Seneral Hospital.

510(k) Number: K032034

Prescription Use Per 21CFR 801.109 OR

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