POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED

K032374 · Perusahaan Getah Asas Sdn. Bhd. · LZC · Oct 22, 2003 · General Hospital

Device Facts

• Record ID: K032374
• Device Name: POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
• Applicant: Perusahaan Getah Asas Sdn. Bhd.
• Product Code: LZC · General Hospital
• Decision Date: Oct 22, 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. Tested for use with Chemotherapy Drugs.

Device Story

Disposable nitrile patient examination glove; intended for use by healthcare professionals to prevent cross-contamination between patient and examiner. Device is worn on hand or finger during medical examinations. Specifically tested for use with chemotherapy drugs. Available in blue, green, violet, or white (non-colored).

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile material; powder-free; disposable; available in multiple colors (blue, green, violet, white).

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner. Tested for use with chemotherapy drugs.

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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## MAR 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Perusahaan Getah Asas. Sdn. Bhd. C/O Mr. Barry S. Sall Principal Consultant PAREXEL consulting 200 West Street Waltham, Massachusetts 02451

Re: K032374/A3

Trade/Device Name: Powder-Free Nitrile Patient Chemotherapy Examination Glove, Blue or Green or Violet or White (Non-colored) Colored Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Codes: LZC Dated: February 18, 2008 Received: February 19, 2008

Dear Mr. Sall:

This letter corrects our substantially equivalent letter of October 22, 2003.

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 (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 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. Sall

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 continue 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] http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). 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.

Chris S. Imbo, Ph.D.

Chiu S. Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Rev. 1 ; Section 3

Page 1 of 1

510 (K) Number (if known) : K032374

Device Name : Powder-free Nitrile Patient Chemotherapy Examination Glove, Blue or Green or Violet or White (Non-colored) Colored

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.

Tested for use with Chemotherapy Drugs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cat Ary for Chant Ler 10/15/03

n of Anesthesiology. General Hospital. on Control Dental De

510(k) Number: K022374

Prescription Use ( Per 21 CFR 801. 109 ) OR

Over-The-Counter Use

( Optional Format 1-2-96 )