POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

K994416 · Flexitech Sdn. Bhd. · LYY · Feb 3, 2000 · General Hospital

Device Facts

• Record ID: K994416
• Device Name: POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
• Applicant: Flexitech Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Feb 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Nitrile examination glove; disposable; worn on examiner's hand. Function: barrier protection to prevent cross-contamination between patient and examiner. Used in clinical/medical settings by healthcare professionals. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nitrile material; polymer coated; powder-free; blue color; disposable; non-sterile; examination glove form factor.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 9 - 2000

Mr. Y. F. Hew Factory Manager Flexitech Sdn. Bhd. Lot 5071, Batu 5 ½ Jalan Meru 41050 Klang Selangor, Malaysia

Re : K994416 Trade Name: Nitrile Examination Glove, Polymer Coated Powder Free, Blue Regulatory Class: I Product Code: LZA Dated: December 20, 1999 Received: December 23, 1999

Dear Mr. Hew:

This letter corrects our substantially equivalent letter of February 3, 2000, regarding the Device Name and Product Code.

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 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 regulations 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 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

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Page 2 - Mr. Hew

the Act for devices under the Electronic Product Radiations the Act for devices under the 22000 millions or regulations.

This letter will allow you to begin marketing your device as first recei will arem for market notification. The FDA described in your sisting providence of your device to a legally marketed predicate device results in a classification for your marketed predicate device rebares in to proceed to the market.

If you desire specific advice for your device on our labeling II you desire Specific advice acciditionally 809.10 for in regulacion (21 crk rares), please contact the Office of Compliance at [phone]. Additionally, for questions on Compliance at (301) of ising of your device, please contact the Dromocion and advertibility or Jose-4639. Also, please note the Orice Or Compiland, "Misbranding by reference to ene regulation scation" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obcained from the bivibion or [phone] or [phone] or at at Its coll-free namber (0:0)/www.fda,gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A 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 a logo with the word "FLEXI" in bold, block letters at the top. Below the word, there is a rectangular shape that is divided into two parts. The left part of the rectangle is white, while the right part is black. The logo has a simple and modern design.

## LEXITECH SDN. BH

Vo: 165532 - 1

x 5071, Batu 5 1/2, Jalan Meru, 41050 Klang, Selangor, Malaysia. Tel: [phone] Fax: [phone]

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Indications for Use Statement. 3.0

## INDICATIONS FOR USE

FLEXITECH SDN BHD Applicant :

K9944-16 510(k) Number

Device Name: Polymer Coated Powder Free Nitrile Examination Gloves, BLUE

Indication For Use :

This glove is disposable and intended for medical purpose that is worn on the examiner's hand 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)

Qlin S. Lin

Mivision Sign-Off) Division of Dental, Infection Control, And Ceneral Hospital De 1991. Number -

cription Use Per 21 CFR 801.109 OR Over-The-Counter : (Optional Format 1-2-96)