SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES

K050455 · Zibo Blue Intco Plastic & Rubber Products Co., Ltd. · LYZ · Mar 29, 2005 · General Hospital

Device Facts

• Record ID: K050455
• Device Name: SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES
• Applicant: Zibo Blue Intco Plastic & Rubber Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Mar 29, 2005
• 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 on the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Device Story

Patient Vinyl Examination Gloves are disposable devices worn on hands or fingers by healthcare examiners. Used in clinical settings to provide a protective barrier, preventing cross-contamination between the examiner and the patient. Device is a passive physical barrier; no electronic, mechanical, or software components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable vinyl examination glove; powdered; Class I medical device; meets 21 CFR 880.6250 requirements.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050455

Trade/Device Name: Patient Vinyl Examination Gloves, Powdered 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 we have forlewed younge determined the device is substantially equivalent (for the relerenced above and nave abouting 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 Amendments, of to do would 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 provinces or 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 cash be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear. or router announcements concerning your device in the Eederal Register.

## MAR 2 9 2005

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Page 2 - Ms. Abell

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that TDA s issualled of a backanians with other requirements mean that FDA has made a decommanent in administered by other Federal agencies. of the Act of ally rederal statutes and reguirements, including, but not limited to: registration You must comply with an the Fee s requirements (21 CFR Part 801); good manufacturing practice (200); and ifsung (21 CFK I at 607), laoolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality of economy of Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-542 of the 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maliering , the stantial equivalence of your device to a premarket notification. The FDF mailing on 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), If you desire specific advice for your de at [phone]. Also, please note the regulation prease contact the Other of Other promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general mironmates and Consumer Assistance at its toll-free Division of Stilland of Still 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

## INDICATIONS FOR USE

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

510(k) Number: K050455

Patient Vinyl Examination Gloves, Powdered Device Name:

Indications of Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between paties: and examiner (21CFR 880.6250)

Prescription Use ________________

And/Or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Factory Initials: _____________

Ludia H. Murphy 3/24/15

in of Anestherology, General Hospitz : Ction Control, Dental Devices

:) Number 1650453