SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES

K050450 · Zibo Blue Intco Plastic & Rubber Products Co., Ltd. · LYZ · Apr 4, 2005 · General Hospital

Device Facts

• Record ID: K050450
• Device Name: SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES
• Applicant: Zibo Blue Intco Plastic & Rubber Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Apr 4, 2005
• 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 personnel to provide a protective barrier on hands or fingers during patient examinations. Function as a physical barrier to prevent cross-contamination between patient and examiner. Intended for over-the-counter use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Vinyl (Polyvinyl Chloride). Form factor: Disposable, powder-free, non-sterile examination glove. Energy source: None. Connectivity: None.

Indications for Use

Indicated for use as a disposable medical glove worn on the 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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DEPARTMENT OF HEALTH & HUMAN SERVICES-USA

APR - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zibo Blue INTCO Plastic & Rubber Products Company Limited C/O Ms. Karen Abell Official Correspondent Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710

Re: K050450

.

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: January 15, 2005 Received: February 23, 2005

Dear Ms. Abell:

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 mendments, or to devices that have been reclassified in accordance with the provisions of / Innonements, or to we we 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 controls province 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 Nr.), it may of cashed 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 - Ms. Abell

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 moun that I Dr may Federal statutes and regulations administered by other Federal agencies. of the For of all - Four all the Act's requirements, including, but not limited to: registration r ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 es read on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betrenir product radiation 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) I mis lotor will and n yourse of substantial equivalence of your device to a premaired predicated. - I a device results 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), r you deems of the Office of 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 overn 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,

Cure

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

Enclosure

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Zibo Blue INTCO Plastic & Rubber Products Co., Ltd. Qilu Chmical Industrial Area Zibo, Shandong China 255414

## INDICATIONS FOR USE

Zibo Blue INTCO Plastic & Rubber Products Co., LTD Applicant:

K050450 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

Over the Counter Use X

Factory Initials wff

あるときていましたときになるところです。そうでするときになっていた

Judy L. Humphrey, D

Anston Sign-Off) Asion of Anesthesiology, General Hospital, rection Control, Dental Devices

) Number: 150452