PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)

K990502 · Flexitech Sdn. Bhd. · LYY · Apr 2, 1999 · General Hospital

Device Facts

• Record ID: K990502
• Device Name: PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
• Applicant: Flexitech Sdn. Bhd.
• Product Code: LYY · 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

Pre-powdered latex examination gloves; intended for use by healthcare professionals to provide a protective barrier between examiner and patient; prevents cross-contamination; disposable; worn on hands.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Latex. Form factor: Examination glove. Feature: Pre-powdered. Labeling claim: Protein content 100 micrograms or less.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is written in a sans-serif font and is arranged in a circular fashion to follow the shape of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1999 APR

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 : K990502 Pre-Powdered Latex Examination Gloves Trade Name: With Protein Content Labeling Claim (100 Micrograms or Less) Regulatory Class: I Product Code: LYY February 12, 1999 Dated: February 17, 1999 Received:

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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ 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 requlation 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 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 to
premarket notification" (21 CFR 807.97). Other gener 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/dsmamain.html".

Sincerely yours,

Patricia Cucenith /for

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 rectangle divided into two sections. The left section is white, and the right section is black.

## FLEXITECH SDN. BHD

mpany No: 165532 - M Lot 5071, Batu 5 1/2, Jalan Meru, 41050 Klang, Selangor, Malaysia. Tel: [phone]-Fax:-03-6379878 NEW TEL: [phone] FAX : [phone]

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## 3.0 Indications for Use Statement.

## INDICATIONS FOR USE

FLEXITECH SDN BHD Applicant :

510(k) Number K990502J

PrePowdered Latex Examination Gloves with Protein claim. ( Device Name: (N

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.

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| Concurrence of CDRH, Office Of Device Evaluation (ODE) | |
|------------------------------------------------------------------------|---------|
| <i>Chin S. Lin</i> | |
| (Division Sign-Off) | |
| Division of Dental, Infection Control,<br>and General Hospital Devices | |
| 510(k) Number | K990502 |

| Prescription Use<br>Per 21 CFR 801.109 | | OR | Over-The-Counter<br>(Optional Format 1-2-96) | X |
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