POWDERED LATEX EXAMINATION GLOVES, NON-STERILE

K984125 · Kilang Barangan Getah Dioh · LYY · Feb 9, 1999 · General Hospital

Device Facts

• Record ID: K984125
• Device Name: POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
• Applicant: Kilang Barangan Getah Dioh
• Product Code: LYY · General Hospital
• Decision Date: Feb 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

Device is a disposable powdered latex examination glove. Worn by healthcare professionals on hands or fingers during patient examinations. Primary function is to serve as a protective barrier to prevent cross-contamination between the patient and the examiner. Device is intended for single use.

Clinical Evidence

bench testing only

Technological Characteristics

Material: Latex. Form factor: Disposable glove. Surface: Powdered. Sterility: Sterile.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners on hands or fingers to prevent cross-contamination between patient and examiner.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Mr. Norli Bin Manaff General Manager Kilang Barangan Getah Dioh Lot 9, Kawasan Perindustrian Dioh 72000 Kuala Pilah, Negeri Sembilan Darul Khusus MALAYSIA

Re : K984125 Powdered Latex Examination Gloves, Non-Trade Name: Sterile Regulatory Class: I Product Code: LYY Dated: January 5, 1999 Received: January 14, 1999

Dear Mr. Manaff:

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 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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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Page 2 - Mr. Manaff

through 542 of the Act for devices under the Electronic Chrough 542 or the net 101 xevisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as Inis lecter will arrow your on responsibilication. The FDA described in your six in puivalence of your device to a legally Finding of Bubbeaneral ogaresults in a classification for your marketed predicate device robated in the to proceed to the market.

If you desire specific advice for your device on our labeling II you debire opeonate and additionally 809.10 for in regaraciasmostic devices), please contact the Office of Villo draghosere actrices// productionally, for questions on Compriance at (30), and advertising of your device, please contact che promotion and advences [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obcation from eno umber [phone] or [phone] or at its internet address

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

Sincerely yours,

Timothy A. Ulatowski

Tim 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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## INDICATIONS FOR USE

Applicant : Kilang Barangan Getah Dioh

K984125 510(k) Number (if known) :

Device Name : _ Powdered Latex Examination Gloves

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.

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Concurrence of CDRH Office of Device Evaluation (ODE)

Olin S. Lin
(Division Sign-Off)

Division of Denial. Infection Control, and General Hospital Devices 510(k) Number

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter

(Optional Format 1-2-96)

* For a new submission, do NOT fill in the 510(k) number blank.