NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)

K984356 · Perusahaan Getah Asas Sdn. Bhd. · LZA · Jan 8, 1999 · General Hospital

Device Facts

• Record ID: K984356
• Device Name: NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)
• Applicant: Perusahaan Getah Asas Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 8, 1999
• 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

Nitrile patient examination glove; disposable; worn on examiner's hand or finger. Function: barrier protection to prevent cross-contamination between patient and examiner. Used in clinical or medical settings by healthcare providers. Device is prepowdered; blue or green colored.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile material; prepowdered; blue or green color; disposable; non-sterile; form factor is a hand-worn glove.

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. Suitable for over-the-counter use.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 8 1999

Mr. Bob Chan General Manager Perusahaan Getah Asas Sdn. Bhd. Lot 754, Jalan Haji Sirat, Off Jalan Kapar, P.O. Box 188, 41720 Klang, Selangor Darul Ehsan, MALAYSIA

Re: K984356 Trade Name: Nitrile Patient Examination Glove, Blue or Green Colored, Prepowdered USP Requlatory Class: T Product Code: LZA Dated: November 25, 1998 Received: December 7, 1998

Dear Mr. Chan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Chan

through 542 of the Act for devices under the Electronic chrough Siz or on Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA descriped in four tial equivalence of your device to a legally Finding of subbeancear equired in a classification for your marketed predicate mits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamajn.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 3

Page 1 of 1

510 (K) Number (if known): K984356

Device Name : Nitrile Patient Examination Glove, Powdered

Name : Nitrile Patient Examination Glove, Powdered (Pre-)

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clim Silin

(Division Sign-Off) Division of Demal, Infection Control, and General Hospital Device

510(k) Number K984356

Prescription Use ( Per 21 CFR 801. 109 ) OR

Over-The-Counter Use X

( Optional Format 1-2-96 )