POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR

K013795 · Shen Wei (Usa), Inc. · LYY · Jan 22, 2002 · General Hospital

Device Facts

• Record ID: K013795
• Device Name: POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR
• Applicant: Shen Wei (Usa), Inc.
• Product Code: LYY · General Hospital
• Decision Date: Jan 22, 2002
• 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 or finger to prevent contamination between patient and examiner. Tested for Use with Chemotherapy Drugs.

Device Story

Powder-free latex examination glove; intended for use as a protective barrier between patient and examiner; tested for use with chemotherapy drugs; contains 50 micrograms or less of total water extractable protein per gram; used in clinical settings by healthcare professionals; provides barrier protection to reduce cross-contamination risk.

Clinical Evidence

Bench testing only. Device tested for use with chemotherapy drugs and protein content (50 micrograms or less per gram).

Technological Characteristics

Latex material; powder-free; contains 50 micrograms or less of total water extractable protein per gram; patient examination glove; class I device.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs.

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 is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 2 2 2002

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

Re: K013795

Trade/Device Name: Powder-Free Latex Examination Gloves Green, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram, Tested For Use with Chemotherapy Drugs Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 10, 2001 Received: November 14, 2001

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 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.gov/cdrh/dsma/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

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## Anachment Two

## INDICATION FOR USE

Shen Wei (USA) Inc. Applicant:

Device Name: Powder-Free Latex Examination Gloves with Aloe-and Protein Claim, Tested for Powderfriee Latex Cammation Color Color Color Color Color Color on or less on water Extractable Profess per gram

Indication For Use:

a disposable device intended for medical purpose that is worn on the examiner's a disposable do not internation belween patient and examiner.

Tested for Use with Chemotherapy Drugs.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Qhin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital F (Jik) Number _

Prescription Use Per 21CFR 801 109 OR

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