POWDER FREE NITRILE EXAMINATION GLOVES

K990495 · Flexitech Sdn. Bhd. · LZA · Apr 2, 1999 · General Hospital

Device Facts

• Record ID: K990495
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES
• Applicant: Flexitech Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 2, 1999
• 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

Powder-free nitrile examination gloves (blue and green); disposable; worn on examiner's hands. Function: physical barrier to prevent cross-contamination between patient and examiner during medical examinations. Used in clinical settings by healthcare professionals. Benefit: infection control via barrier protection.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Nitrile rubber. Form factor: Disposable examination glove. Color: Blue and Green. Feature: Powder-free. Sterilization: Not specified.

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. No specific age or disease state contraindications provided.

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1995

> Mr. Kenny H. N. Liew Executive Director FLEXITECH SDN. SDN.BHD. Lot 5071, Batu 5 1/2 Jalan Meru, 41050 Klang, Selangor Darul Ehsan, MALAYSIA

Re : K990495 Powder-Free Nitrile Examination Gloves (Blue Trade Name: and Green) Requlatory Class: I Product Code: LZA February 12, 1999 Dated: Received: February 17, 1999

Dear Mr. Kenny H. N. Liew

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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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. Kenny H. N. Liew

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 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 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" (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,

Patrice Cuente /foe

Timothy A. Ulatowski 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 word "FLEXI" in bold, uppercase letters. Below the word is a black rectangle with a white square on the left side. The white square takes up about one-third of the rectangle's area. The logo appears to be a stylized representation of the word "FLEXI".

## FLEXITECH SDN. BHD.

Company No: 165532 - M Lot 5071, Batu 5 1/2, Jalan Meru, 41050 Klang, Selangor, Malaysia. Tel: [phone]-Fax: [phone] NEW TEL : [phone] FAX : [phone]

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3.0 Indications for Use Statement.

## INDICATIONS FOR USE

| Applicant : | FLEXITECH SDN BHD |
|---------------|----------------------------------------------------------|
| 510(k) Number | K990495 |
| Device Name: | Powder Free Nitrile Examination Gloves. (Green and 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)

Olin S. Lin

(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 : (Optional Format 1-2-96)