NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR

K990453 · Alliance Rubber Products Sdn. Bhd. · LZA · Mar 9, 1999 · General Hospital

Device Facts

• Record ID: K990453
• Device Name: NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
• Applicant: Alliance Rubber Products Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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 glove; non-sterile; powder-free; green color. Worn on hands by healthcare personnel to provide barrier protection against contamination between patient and provider. Used in clinical or similar settings. Device acts as a physical barrier to prevent transmission of infectious agents or contaminants during patient examination or procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitrile rubber material; powder-free; non-sterile; green color; 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 personnel 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 U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three wavy lines above a human profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 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

K990453 Re : Nitrile Examination Gloves, Powder-Free, Trade Name: Green Color Requlatory Class: I Product Code: LZA Dated: February 9, 1999 February 12, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 the Federal Register. Please note: this response to your 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 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 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 regulation entitled, "Misbranding by reference fo
premarket notification" (21 CFR 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/dsmamain.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

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

Alliance Rubber Products Sdn.Bhd.

Lot 2716 & 2720, MK 7, Kawasan Perindustrian Bukit Panchor, 14300 Nibong Tebal, Pulau Pinang, Malaysia. Company No. : 52446-U Tel : [phone] Fax : [phone] E-mail : [e-mail] Your Ref : Our Ref : CHK/080299/04 Date : 08-02-99 Page :1/1

## ATTACHMENT 2 :

대학교

## INDICATION FOR USE

Applicant : ALLIANCE RUBBER PRODUCTS SDN. BHD.

510(k) Number (if known) :

Device Name : NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE. GREEN COLOR.

Trade Name : ARsoft 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)

Olin S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter

ion Use