GREEN POWDERED LATEX EXAMINATION GLOVES

K993452 · Top Glove Sdn. Bhd. · LYY · Dec 20, 1999 · General Hospital

Device Facts

• Record ID: K993452
• Device Name: GREEN POWDERED LATEX EXAMINATION GLOVES
• Applicant: Top Glove Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Dec 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Powdered Green Latex Examination Gloves (vith minimum length of 280mm) are worn on the hands of Health care and similar personnel to give an additional protection until the arm to prevent contamination between health care personnel and the patient especially for the Emergency Medical Service.

Device Story

Powdered Green Latex Examination Gloves; minimum length 280mm; worn on hands/arms by healthcare personnel; provides barrier protection against contamination; used in clinical and emergency medical service settings; non-sterile examination device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex material; powdered; minimum length 280mm; examination glove form factor.

Indications for Use

Indicated for use by healthcare and similar personnel to prevent cross-contamination between personnel and patients, specifically for Emergency Medical Service applications.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. 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 a bird or abstract human figure, composed of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 1999

Mr. T.S. Puon Factory Manager Top Glove Sdn. Bhd. Lot 4968, Jalan Teratai, Batu 6 Off Jalan Meru, 41050 Klang Selanqor D.E., Malaysia

K993452 Re: Green Powdered Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: LYY Dated: October 11, 1999 Received: October 13, 1999

Dear Mr. Puon:

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 reqistration, 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. ಗ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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

{1}------------------------------------------------

Page 2 - Mr. Puon

obligation you might have under sections 531 through 542 of 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 findinq 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,

Susan Runoco

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The iformation, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.

| Applicant: | TOP GLOVE SDN. BHD. |
|---------------------------|----------------------------------------|
| 510(k) Number (if known): | K993452 * |
| Device Name: | Powdered Green Latex Examination Glove |
| Indications For Use: | |

Powdered Green Latex Examination Gloves (vith minimum length of 280mm) are worn on the hands of Health care and similar personnel to give an additional protection until the arm to prevent contamination between health care personnel and the patient especially for the Emergency Medical Service.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Jamy Surnor for Chris Lin RD

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .

Prescription Use .er 21 CPR 801.109

OR

Over-The-Counter

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

(Optional Format 1-2-96)