GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES

K052922 · Great Glove (China), Inc. · LYZ · Dec 20, 2005 · General Hospital

Device Facts

• Record ID: K052922
• Device Name: GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES
• Applicant: Great Glove (China), Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination Vinyl Powdered Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Powdered vinyl examination glove; disposable; worn on examiner's hand/finger; prevents cross-contamination between patient and examiner; used in clinical settings; provides barrier protection.

Clinical Evidence

Bench testing only.

Technological Characteristics

Vinyl material; powdered; disposable; patient examination glove; Class I device (Product Code LYZ).

Indications for Use

Indicated for use as a disposable medical glove worn by 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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Public Health Service

DEC 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. K.M. Lee Executive Director Great Glove (China) Incorporated 3-4 Floor, No.16 Hua Chang Road Jiangsu 215600, Zhangjiagang CHINA

Re: K052922

Trade/Device Name: Powdered Vinyl Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 7, 2005 Received: December 13, 2005

Dear Mr. Lee:

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 approvisions 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 such additional controls. Existing major regulations affecting (1 Writ), it hay ob back 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. Lee

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease of advisod that 127 to leasiness on that your device complies with other requirements moun that I DAT has made a actes and regulations administered by other Federal agencies. or the Act of any vouth all the Act's requirements, including, but not limited to: registration 1 od intine (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fiscing (21 et read on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quartify ajon control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter while are in J The FDA finding of substantial equivalence of your device to a premaired predicated. - 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 regulation (21 CFR Part 801), 11 you desire specific acerof Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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,

Syrtie y. Michie Omd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): K052922

Device Name: Powdered Vinyl Examination Glove

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Indications For Use:

A patient examination Vinyl Powdered Gloves is a disposable A patient chamilable medical purpose that is worn on the device Intended for media. Contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula H. Murray D 12/20/05

School, Dental Devices
K-052922

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