VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE

K042028 · Zibo Borui Plastic & Rubber Products Co., Ltd. · LYZ · Aug 9, 2004 · General Hospital

Device Facts

• Record ID: K042028
• Device Name: VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE
• Applicant: Zibo Borui Plastic & Rubber Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Aug 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended 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

Powder-free vinyl examination glove; disposable; worn on hands/fingers by healthcare personnel. Functions as a physical barrier to prevent cross-contamination between patient and examiner during medical procedures. Used in clinical settings. Device provides protection through material barrier properties.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vinyl material; powder-free; disposable; Class I medical device; 21 CFR 880.6250.

Indications for Use

Indicated for use as a disposable medical device worn on the hands or fingers by healthcare 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

AUG - 9 2004

Zibo Borui Plastic & Rubber Products Company, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K042028

Trade/Device Name: Powder Free Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 23, 2004 Received: July 28, 2004

Dear Mr. Job:

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 such 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 Eederal Register.

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Page 2 -Mr. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualled of a bases and issues complies with other requirements mean that IDA has made a decommanent and regulations administered by other Federal agencies. of the Act of ally I cueral sales and roganized including, but not limited to: registration You must comply with an the Fict broquits ... ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . and listing (21 CFR Part 607), laceling (21 crss (QS) regulation (21 CFR Part 820); and if requirents as set fortif in the quality bjocking (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 will anow you to began made ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. premiarket notification. The FDF Intellis 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), If you desire specific at 100 ros poliance at [phone]. Also, please note the regulation in 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/dsma/dsmamain.html

Sincerely yours,

Chih-Liang Liu, 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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## Indications for Use

K042028 510(k) Number (if known):

Device Name: __ Powder Free Vinyl Examination Gloves

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)

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulvey

(Division Sign-Off) (Division Sign-Oh)
Division of Anesthesiology, General Hospit Infection Control, Dental D

510(k) Number. K 8428