POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE

K043478 · Shijaizhuang Brilliant Ocean Plastic Co., Ltd. · LYZ · Mar 9, 2005 · General Hospital

Device Facts

• Record ID: K043478
• Device Name: POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
• Applicant: Shijaizhuang Brilliant Ocean Plastic Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Mar 9, 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 purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Powdered yellow synthetic vinyl patient examination gloves; disposable; worn on examiner's hand; prevents contamination between patient and examiner; used in clinical settings; protects both patient and healthcare provider.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic vinyl material; powdered; disposable; patient examination glove; class I device; regulation 880.6250; product code LYZ.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines that curve and flow together. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 9 - 2005

Shijaizhuang Brilliant Ocean Plastic Company Limited C/O Ms. Emmy Tjoeng Marketing Director Shamrock Manufacturing Company 5445 Daniels Street Chino, California 91710

Re: K043478

K043478
Trade/Device Name: Powdered Yellow Synthetic Vinyl Patient Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: February 4, 2005 Received: February 23, 2005

Dear Ms. Tjoeng:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section Fro(t) promaince is substantially equivalent (for the referenced above and nave determined the develly marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed predical Device indications for use stated in the checksates to fegally and of the Medical Device interstate commerce prior to May 20, 1770, the situation with the provisions of
Amendments, or to devices that have been reclassified in a preval of a premarket Amendments, of to devices that have been rocasine approval of a prematice the Federal Food, Drug, and Cosmetic Act (716) mar et et the device, subject to the general
approval application (PMA). You may, therefore, market the Aet include approval appreation (r MA). Tou may and controls provisions of the Act include controls provisions of the Act. The general of the stimes, good manufacturing practice, requirements for annual registian misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
ns affect If your device is classified (see above) into charols. Existing major regulations affecting.
(PMA), it may be subject to such additional Controls. Existing Time 21, Parts (PMA), it may be subject to such additional contributers. Title 21 . Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21 . Federal your device can be found in the Code of Peacharter, wour device in the Federal Register.

{1}------------------------------------------------

Page 2 - Ms. Tjoeng

Please be advised that FDA's issuance of a substantial equivalence determination does not
ement Please be advised that FDA's issuance of a subscribes with other requirements
mean that FDA has made a determination that your devices with other requirements mean that FDA has made a deleminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administer to: registration of the Act or any Federal statutes and reginations authlinited to: registration
You must comply with all the Act step Recep Red Limited to: registration You must comply with all the Act S requirences, including, sod manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807); labelling (21 CFR Party Bor Clark (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); requirements as set forth in the quality systems (Sections 531-542 of the Act);
applicable, the electronic 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)
. The success of the same of the same of the mixelesse of your device to a This letter will allow you to begin malicating your activalence of your device to a
premarket notification. The FDA finding of substantial equivalence and thus, new premarket notification. The FDA miding of substantial of a more of the results and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), If you desire specific advice for your device of the Sun please note the regulation
please contact the Office of Compliance at [phone]. please contact the Office of Comphance at (210) =77, =727 Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21CFR Part 8) entitled, "Misbranding by reference to premail.ities under the Act from the may obtain other general mionhation on your respections in the summer Assistance at its toll-free DIVIsion of Sman Manatar [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ques

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

{2}------------------------------------------------

## Indications for Use

Applicant: Shijiazhuang Brilliant Ocean Plastic Co.Ltd.

510(k) Number (if known):__K043478_

Device Name: _Powdered Yellow Synthetic Vinyl Patient Examination Gloves______________________________________________________________________________________________________

Indications For Use:

A patient examination glove is a disposable device intended for medical purpose that is A patient examiner's hand to prevent 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)

Soujite Michius Omd

a Str. Off na vi Anesthatiblogy, General Hospital, Judon Control, Dental Davices K 043 478 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·