TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE

K992200 · Shen Wei (Usa), Inc. · LYY · Aug 17, 1999 · General Hospital

Device Facts

• Record ID: K992200
• Device Name: TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE
• Applicant: Shen Wei (Usa), Inc.
• Product Code: LYY · General Hospital
• Decision Date: Aug 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Textured Powder-Free Latex Exam Glove with Aloe Vera and Protein Content Labeling Claim, Green is 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 latex examination glove; contains aloe vera; protein content labeled as 50 mcg or less per gram. Device worn on examiner's hand; acts as physical barrier to prevent cross-contamination between patient and examiner in clinical settings. Not intended for chemical barrier protection.

Clinical Evidence

No clinical data provided; device is a standard examination glove.

Technological Characteristics

Latex material; powder-free; textured surface; contains aloe vera; protein content 50 mcg/g or less. 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. 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

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.

AUG 17 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

RE: K992200 Trade Name: Textured Powder-Free Latex Examination Gloves With Aloe Vera Green,contains 50 mcgm or less of total water extractable protein per gram Class: I Product Code: LYY June 29, 1999 Dated: Received: June 30, 1999

Dear Ms. 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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify Failure to comply with the GMP requlation may such assumptions. result in regulatory 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Chou

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 xitro diaqnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and [phone]. 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 Other general information on your responsibilities CFR 807.97). 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,

Patricio Cucarita Flor

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment Two

992200

## INDICATION FOR USE

Shen Wei (USA) Inc. Applicant:

Device Name: Textured Powder-Free Latex Exam Gloves with Aloe Vera and Protein Content .
Labeling Claim, Green Cortforms . 50 million on less prefern per gram

Indication For Use:

Textured Powder-Free Latex Exam Glove with Aloe Vera and Protein Content Labeling Claim, Green is 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.

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Qun S. Lin

Concurrence of CDRH Office of Device Evaluation (ODE)

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

Prescription Use Per 21CFR 801.109 OR

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

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