SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K100294 · Zibo Yinghao Medical Products Co., Ltd. · LYZ · May 14, 2010 · General Hospital

Device Facts

• Record ID: K100294
• Device Name: SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
• Applicant: Zibo Yinghao Medical Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: May 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for 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, non-colored gloves. Used by healthcare personnel to cover hands/fingers during examinations to provide a barrier against cross-contamination between patient and examiner. Device is a standard patient examination glove intended for medical purposes.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Vinyl material; powder-free; non-sterile; non-colored; disposable; form factor is a hand-worn glove. Class I device per 21 CFR 880.6250.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.

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

Zibo Yinghao Medical Products Company, Limited C/O Mr. Frank Liu President Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710

MAY 1 4 2010

Re: K100294

Trade/Device Name: Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Non Colored Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 16, 2010 Received: April 20, 2010

Dear Mr. Liu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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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.html 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

R for

Anthony D. Watson, B.S., M.S., M.B.A. 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 Yinghao Medical Products Co., Ltd.

No. 6 Yifan Road, Technology Industry Park Zhangdian District, Zibo, Shandong, China Phone: [phone]

## INDICATIONS FOR USE

Zibo Yinghao Medical Products Co., Ltd. Applicant:

510(k) Number:

Device Name:

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

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 _________________________________________________________________________________________________________________________________________________________

Factory Initials

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

K100094 510(k) Number: