BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW

K032323 · Long First (Xiamen) Plastics Co., Ltd. · LYZ · Oct 7, 2003 · General Hospital

Device Facts

• Record ID: K032323
• Device Name: BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
• Applicant: Long First (Xiamen) Plastics Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Oct 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Device Story

Device is a powdered synthetic vinyl patient examination glove. Used by healthcare and similar personnel to provide a protective barrier on the hands. Primary function is to prevent cross-contamination between the wearer and the patient during medical examinations or procedures. Device is a disposable, single-use physical barrier.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Synthetic vinyl. Form factor: Powdered patient examination glove. Color: Yellow. Device is a physical barrier; no electronic, sensing, or software components.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier on the hands to prevent cross-contamination between the personnel and the patient.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's authority and commitment to public service.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT - 7 2003

Long First (Xiamen) Plastics Company Limited C/O Ms Stone Chen President Kaohsiung Brother Products Company 23 Kooshan 3rd Road Kaosiung Taiwan, R.O.C.

Re: K032323

Trade/Device Name: Brothers Powered Synthetic Vinyl Patient Examination Gloves Yellow Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 24, 2003 Received: July 29, 2003

Dear Mr. Chen:

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 Federal Register.

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Page 2 - Mr. Chen

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact 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 Division 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,

Clus L

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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Image /page/2/Picture/1 description: The image shows a logo with a stylized letter 'B' inside a square. The 'B' is formed by two horizontally stacked shapes, each resembling a modified letter 'D' or a half-oval with a slanted, angular edge on the left side. The logo is filled with a solid black color, contrasting with the white background of the square.

KAOHSIUNG BROTHERS PRODUCTS CORPORATION

Office : 23, Kooshan 3rd Road, Kaohsiung, Taiwan, R.O.C. :886-7-5612201~5 Tel : [phone]~7 Fax E-Mai I : [e-mail]

Chris S. Ulm

## ATTACHMENT B

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number

## INDICATION FOR USE STATEMENT

K032323 510K Number (if known): ______________________________________________________________________________________________________________________________________________________ Device Name: Powdered Synthetic Vinyl Patient Examination Gloves, Yellow

Indications For Use:

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

LONG FIRST ( XIAMEN ) PLASTICS CO., LTD.

stone coen

STONE CHEN

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use

Over-The-Counter Use

( Per 21 CFR 801.109 )

(Optional Format 1-2-96)