POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES

K091431 · Zibo Yusheng Plastic Products Co., Ltd. · LYZ · Jul 8, 2009 · General Hospital

Device Facts

• Record ID: K091431
• Device Name: POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
• Applicant: Zibo Yusheng Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Device Story

Patient Vinyl Examination Gloves are disposable, non-sterile, powder-free vinyl gloves. Used by healthcare professionals or individuals in clinical or home settings to provide a protective barrier between the examiner's hands and the patient. The device functions as a physical barrier to prevent cross-contamination during medical examinations or procedures. No electronic, software, or complex mechanical components involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Vinyl. Form factor: Disposable, powder-free, non-sterile examination glove. Energy source: None. Connectivity: None. Sterilization: Not sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers to prevent cross-contamination between patient and examiner. Intended for over-the-counter use.

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/0 description: The image shows the logo for the U.S. Department of Health and 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 image of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zibo Yusheng Plastic Products Company, Limited Mr. John Zhao Chief Operating Officer Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710

JUL - 8 2009

Re: K091431

Trade/Device Name: Patient Vinyl Examination Gloves, Yellow, Powder free,

Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 6, 2009 Received: May 13, 2009

#### Dear Mr. Zhao:

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 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 - Mr. Zhao

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

Anthony V. Montan, for
B.S., M.S.

Susan Runner, D.D.S., M.A. Acting 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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# Zibo Yusheng Plastic Products Co., Ltd.

Li Wang Village, Zhoujia District, Hengtai County Zibo, Shandong, China

# INDICATIONS FOR USE

Zibo Yusheng Plastic Products Co., Ltd. Applicant:

510(k) Number:

Device Name:

Patient Vinyl Examination Gloves, Yellow, Powder free, Non-Sterile

Indications of Use:

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Prescription Use

Over the Counter Use ___ X

Factory Initials

Shile A Murphy KO

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: