BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED

K031768 · Perusahaan Getah Asas Sdn. Bhd. · LZA · Aug 1, 2003 · General Hospital

Device Facts

• Record ID: K031768
• Device Name: BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
• Applicant: Perusahaan Getah Asas Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 1, 2003
• 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 on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Barrier-Pro™ Co-polymer Patient Examination Glove; disposable synthetic glove; material: Butadiene Methylmetacrylate Methacrylic Acid Co-polymer rubber. Used in clinical settings by healthcare professionals to provide barrier protection; prevents cross-contamination between examiner and patient. Device is powdered; available in white (non-colored) or green. Simple physical barrier device; no electronic or software components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Synthetic Butadiene Methylmetacrylate Methacrylic Acid Co-polymer rubber; powdered; disposable; non-sterile; available in white or green.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Perusahaan Getah Asas Sdn Bhd C/O Mr. James F. Logan Director General Medical Reports Exchange 1301 Defence Highway Gambrills, Maryland 21034

Re: K031768

Trade/Device Name: Barrier-Pro™ Co-Polymer Patient Examination Gloves, Powdered, White (Non-colored) or Green colored Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: June 5, 2003 Received: June 9, 2003

Dear Mr. Logan:

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.

AUG - 1 2003

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Page 2 - Mr. Logan

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 (OS) 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,

Patricia Cincinato ffa

Susan Runner, DDS, MA Interim 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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Rev. 1, Section 3.

Page I of I

510 (K) Number (if known) : __K031768

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Device Name

: Barrier-ProTM Co-polymer Patient Examination Glove, Powdered, White (non-colored) or Green colored

Note: (a) Glove made from Synthetic Butadiene Methylmetacrylate Methacrylic Acid Co-polymer Rubber

(b)Barrier-Pro™ is a registered trade mark of Dow Reichhold Specialty Latex LLC

Indications For Use

A 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE II: NUMDED)

Concurrence of CDRH, Office of Device Evaluation (ODF)

SRB In Clin

esthesiology. Gener ontrol. Dental Devi

510(k) Number:

Prescription Use ( Per 21 CFR 801. 109 ) OR

Over-The-Counter Use

( Optional Format 1-2-96 )