ARSOFT

K983146 · Alliance Rubber Products Sdn. Bhd. · LZA · Dec 7, 1998 · General Hospital

Device Facts

• Record ID: K983146
• Device Name: ARSOFT
• Applicant: Alliance Rubber Products Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 7, 1998
• 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 gloves; non-sterile; powder-free. Worn by healthcare personnel; provides barrier protection to prevent cross-contamination between patient and clinician. Used in clinical settings. Device acts as a physical barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile rubber material; powder-free; non-sterile; blue color. Form factor is a standard examination glove. No electronic components, software, or energy sources.

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)

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Image /page/0/Picture/2 description: The image shows a partial view of a logo or emblem. The visible portion includes the stylized depiction of three human profiles facing to the right, arranged in a stacked formation. To the left of the profiles, there is a curved text that reads "DEPARTMENT OF HEALTH &". The text is oriented vertically, following the curve of the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1998 DEC

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

Re : K983146 Arsoft, Nitrile Examination Gloves, Non-Trade Name: Sterile, Powder-Free Blue Regulatory Class: I Product Code: LZA October 24, 1998 Dated: Received: November 5, 1998

Dear Mr. Chua Hooi 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 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 The general controls controls provisions of the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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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Paqe 2 - Mr. Chua Hooi Koon:

through 542 of the Act for devices under the Electronic Product Radiation 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 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 diaqnostic 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 to
premarket notification" (21CFR 807.97). Other genera Other qeneral 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

y A. Ulatowski 11 i mo 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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Image /page/2/Picture/0 description: The image shows the logo for Alliance Rubber Products Sdn.Bhd. The logo consists of a stylized graphic to the left of the company name. The company name is written in a serif font. The graphic is a black, abstract design.

Lot 2716 & 2720, MK 7, Kawasan Perindustrian Bukit Panchor, 14300 Nibong Tebal, Company No. : 52446-U Pulau Pinang, Malaysia. Fax : [phone] E-mail : [e-mail] Tel : [phone] Our Ref : CHK/150898/04 Date : 15-08-98 Page : 1/1 Your Ref :

## ATTACHMENT 2 :

## INDICATION FOR USE

Applicant : ALLIANCE RUBBER PRODUCTS SDN. BHD.

510(k) Number (if known) : _ K 98 31 4 6

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

Trade Name : Arsoft OR other client's trade name.

Indication For Usc :

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)

Chun S. Lin
(Division Sign-Off)

(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devic

510(k) Number K983146

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter

er-The-Counter