POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES

K092100 · Tangshan Hongxing Plastic Products Co., Ltd. · LYZ · Sep 18, 2009 · General Hospital

Device Facts

• Record ID: K092100
• Device Name: POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
• Applicant: Tangshan Hongxing Plastic Products Co., Ltd.
• 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, Powder-Free, Non-Sterile; disposable medical device; worn on examiner's hands or fingers; prevents cross-contamination between patient and examiner; intended for general medical examination use; over-the-counter availability.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Vinyl material; powder-free; non-sterile; disposable; form factor: hand/finger glove; regulation 880.6250; product code LYZ.

Indications for Use

Indicated for use as a disposable medical device worn on the hands or fingers of examiners 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

SEP 8 2009

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

Tangshan Hongxing Plastic Products Company, Limited C/O Mr. John Zhao Official Correspondent Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710

Re: K092100 ·

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 9, 2009 Received: September 11, 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/ucm.115809.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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthony D avatar per
Susan Runher, 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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# Tangshan Hongxing Plastic Products Co., Ltd.

South of Ningtuo Village, Luannan County Tangshan City, China

# INDICATIONS FOR USE

Tangshan Hongxing Plastic Products Co., Ltd. Applicant:

510(k) Number:

Patient Vinyl Examination Gloves, Powderfree, Non-Sterile Device Name: 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

Shels A. Murphy

(Division Sign-Off)

Division of Anesthesiology, General Hospital. nfection Control, Dental Devices

510(k) Number: K092108