POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS

K013793 · Shen Wei (Usa), Inc. · LYY · Jan 22, 2002 · General Hospital

Device Facts

• Record ID: K013793
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS
• 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 to prevent contamination between patient and examiner.

Device Story

Textured powder-free latex examination gloves; intended for medical use to prevent cross-contamination between patient and examiner. Device worn on examiner's hands during clinical examinations. Contains 50 micrograms or less of total water extractable protein per gram to reduce potential for latex sensitivity. Disposable design.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Latex material; textured surface; powder-free; contains 50 micrograms or less of total water extractable protein per gram; Class I medical device.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner.

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 shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing health, services, and people. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

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: K013793

Trade/Device Name: Textured Powder-Free Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram 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.

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

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of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal barates and equirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsung (21 CFR Part 007), labeling (21 CFR Part 820); and if requirents as set form in als quadiation 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 This letter will anow you to began mainening your of substantial equivalence of your device to 310(k) premarket nourication: "The 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 II you desire specific ad not 2019 10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and Office of Colliphanoo at (301) see contact the Office of Compliance at [phone]. advertising or you the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notification (210) It it it it is 0011).
the Act may be obtained from the Division of Small Manufacturers, International and the Act may of obtained install free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ulatowski

Timoth . 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: Textured Powder-Free Latex Examination Gloves Contains 50 Micrograms or Less of Total Water Extractable Protein per Gram

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.

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Concurrence of CDRH: Office of Device Evaluation (ODE)

Clim S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev E10(k) Number .

OF.

Prescription Use Per 21CFR 801.109 Over-The Counter (Optional Format 1-2-96)