NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.

K990486 · Alliance Rubber Products Sdn. Bhd. · LZA · Apr 23, 1999 · General Hospital

Device Facts

• Record ID: K990486
• Device Name: NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.
• Applicant: Alliance Rubber Products Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Story

Nitrile examination gloves; non-sterile; powdered; blue color. Worn by healthcare and similar personnel on hands. Acts as physical barrier to prevent cross-contamination between wearer and patient. Used in clinical settings. Simple protective equipment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile rubber material; powdered; blue color; non-sterile; examination glove form factor.

Indications for Use

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

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle or bird, depicted with flowing lines to represent its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1999

Mr. Chua Hooi Koon Alliance Rubber Products Sdn. Bhd. Lot 2716 & 2720, MK 7, Kawasan Perindustrian Bukit Panchor, 14300 Nibong Tebal, Pulau Pinang, MALAYSIA

Re : K990486 Nitrile Examination Gloves, Non-Sterile, Trade Name: Powdered, Color: Blue Regulatory Class: I Product Code: LZA Dated: February 9, 1999 February 16, 1999 Received:

Dear Mr. Koon

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 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 The general controls provisions of the Act 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 (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. ರ್ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

{1}------------------------------------------------

Page 2 - Mr. Koon

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sia in puivalence of your device to a legally rinding of bubbeaneral squresults in a classification for your marketed predicate actes your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (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 compreason and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the office of comprisid, "Misbranding by reference to the regulation chercica) hibbidnaning by Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained itsm one number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Alliance Rubber Products Sdn.Bhd. The logo consists of a stylized knot-like symbol on the left, followed by the company name in a serif font. The text is aligned horizontally with the symbol. The overall impression is a professional and established brand identity.

ATTACHMENT 2 :

## INDICATION FOR USE

Applicant : ALLIANCE RUBBER PRODUCTS SDN. BHD.

510(k) Number (if known) :

Device Name : NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.

Trade Name : ARsafe or other client's trade name.

Indication For Use :

A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Concurrence of CDRH Office of Device Evaluation (ODE)

Qlin S. Lain
(Division Sign-Off)

Division of Dental, Infection Control,
and General Hospital Devices

510(k) Number K990486

OR

Prescription Use Per 21 CFR 801.109 Over-The-Counter

unter