POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED

K031625 · Perusahaan Getah Asas Sdn. Bhd. · LZA · Aug 1, 2003 · General Hospital

Device Facts

• Record ID: K031625
• Device Name: POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND 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

Powder-free Barrier-Pro™ Co-polymer examination glove; disposable device; worn on examiner's hand or finger; prevents contamination between patient and examiner; manufactured from synthetic butadiene methylmethacrylate methacrylic acid co-polymer rubber; white or green colored; intended for medical purposes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Synthetic butadiene methylmethacrylate methacrylic acid co-polymer rubber. Form factor: Powder-free examination glove. Colors: White or green. Class I device.

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/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

AUG - 1 2003

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 Defense Highway Gambrills, Maryland 21034

Re: K031625

Trade/Device Name: Powder-free Barrier-Pro™ Co-Polymer Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: 80 LZA Dated: July 24, 2003 Received: July 28, 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.

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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 (301) 594 - 4618. 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 tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Rutina Creciente for

Susan Runner, DD, 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 1 of 1

510 (K) Number (if known) :

Devicc Name

・・ー

: Powder-free Barrier-Pro™ Co-polymer Patient Examination Clove, White (non-colored) or Green colored

Notc: (a) Glove made from Synthetic Butadiene Methylmetacrylate Mcthacrylic Acid Co-polymer Rubber

(h)Barrier-ProTM is a registered trade mark of Dow Reichhold Specialty Latex LLC

Indications For Use

A patient cxamination 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.

(P).E.A.SE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQTITIER IPAGE IF NEFDED)

Concurrence of CDRII, Office of Device Evaluation (ODE)

SB for Chui lin

(Division
Division of
Infection Contrology General Hospital,
al Devices

510(k) Number. K031625

Prescription Use ( Per 21 CFR 801. 109 ) ાર

Over-The-Counter Use

( Optional Format 1-2-96 )