POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES

K092000 · Shangdong Zibo Shanchuan Medical Instruments Co. · LYZ · Sep 18, 2009 · General Hospital

Device Facts

• Record ID: K092000
• Device Name: POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
• Applicant: Shangdong Zibo Shanchuan Medical Instruments Co.
• Product Code: LYZ · General Hospital
• Decision Date: Sep 18, 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 gloves. Used by healthcare professionals or patients in clinical or home settings to provide a protective barrier on hands/fingers. Primary function is to prevent cross-contamination between examiner and patient during medical examinations or procedures. Device is a physical barrier; no electronic or mechanical components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Vinyl material; powder-free; non-sterile; disposable; form-fitting glove design.

Indications for Use

Indicated for use as a disposable medical glove worn on examiner's hands 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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### SEP 1 8 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Shandong Zibo Shanchuan Medical Instruments Company, Limited C/O Mr. John Zhao Official Correspondent Basic Medical Industries 12390 East End Avenue Chino, California 91710

Re: K092000

Trade/Device Name: Patient Vinyl Examination Gloves, PowderFree, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 4, 2009 Received: September 9, 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Antony C. Aniston
Susan Runner, D.D.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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# Shandong Zibo Shanchuan Medical Instrument Co., Ltd.

Shanchuan Road, Chengnan Town, Zichuan District, Shandong, China

## INDICATIONS FOR USE

Shandong Zibo Shanchuan Medical Instrument Co., Ltd. Applicant:

510(k) Number:

Device Name:

Patient Vinyl Examination Gloves, Powderfree, 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

X Over the Counter Use

Factory Initials

Shade A Murphy D
(Division Sign-Off)

Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K042077