SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE

K993680 · Top Glove Sdn. Bhd. · LYZ · Dec 13, 1999 · General Hospital

Device Facts

• Record ID: K993680
• Device Name: SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
• Applicant: Top Glove Sdn. Bhd.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Synthetic Vinyl Medical Examination Powder Free Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Story

Synthetic vinyl medical examination gloves; worn on hands by healthcare personnel; barrier protection to prevent contamination between wearer and patient. Device is a disposable, non-sterile, powder-free glove used in clinical or similar settings. No electronic components, software, or algorithms involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic vinyl material; powder-free; disposable; non-sterile; form factor is a hand-worn glove. No electronic, software, or energy-based components.

Indications for Use

Indicated for use by health care and similar personnel to prevent cross-contamination between the wearer and the patient.

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 U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 1999

Mr. Loo Sun Nooi Assistant QA Manager Top Glove Sdn. Bhd. Lot 4968 Jalan Teratai Batu 6 Off Jalan Meru 41050 Klang, Selangor D.E., Malaysia

> Re: K993680 Synthetic Vinyl Medical Examination Powder Trade Name: Free Gloves Requlatory Class: I Product Code: LYZ November 23, 1999 Dated: November 29, 1999 Received:

Dear Mr. Nooi:

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಕ substantially equivalent determination assumes compliance with the Good Manufacturinq 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

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

Page 2 - Mr. Nooi

obligation you might have under sections 531 through 542 of obligation you might have ahaor betronic Product Radiation the Act for devices ander on Federal laws or regulations.

This letter will allow you to begin marketing your device as This icecci will arenarket notification. The FDA described in your 510 (i) p=umance of your device to a legally Finding of Subscancial Oquination a classification for your marketed predicate device rubablice to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific advice additionally 809.10 for in regulacion (21 crk rares), please contact the Office of Compliance at [phone]. Additionally, for questions on compriated as (od advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to the regulation encreased, "histian" (1) Other general premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obtained from the Division of 638-2044 or [phone] or at at its coll-free namber (05)/www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timoth Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

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

## INDICATIONS FOR USE

| Applicant: ___________________________________________________________________________________________________________________________________________________________________ | TOP GLOVE SDN. BHD. | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--|-------------------------------------------------------|--|--|--|
| 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ | | | 993680 | | | |
| Device Name: _________________________________________________________________________________________________________________________________________________________________ | | | SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE | | | |

Indications For Use:

Synthetic Vinyl Medical Examination Powder Free Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Clim S. Lin

sion Sign-Off) on of Dental, Infection C General Hospi «» Number

Prescription Uso Per 21 CPR 801.109

రుష

Over-Ilo-Counter

(Optional Pormal 1-

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