INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED

K993221 · Innovative Gloves Co;, Ltd. · LYY · Nov 5, 1999 · General Hospital

Device Facts

• Record ID: K993221
• Device Name: INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED
• Applicant: Innovative Gloves Co;, Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Nov 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Medical glc ve is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.

Device Story

Latex examination gloves, prepowdered; worn on hands by healthcare personnel; function as physical barrier to prevent cross-contamination between patient and clinician; used in clinical settings; disposable.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Latex material; prepowdered; examination glove form factor; disposable.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1999

Mr. Rajeev Kumar Sood President & CEO Innovative Gloves Company, Ltd. 11, Chotevittayakul 3 Road Khohonq, Hatyai Songkhla 90110 Thailand

Re : K993221 Trade Name: Latex Examination Gloves Prepowdered Requlatory Class: I Product Code: LYY Dated: September 23, 1999 Received: September 27, 1999

Dear Mr. Sood:

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 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 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

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Page 2 - Mr. Sood

obligation you might have under sections 531 through 542 of exigation 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 marroos 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 organs on 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,

hy A. Ulatowski Tir 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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400 14 420403

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## บริษัท ฮินโนเวทีฟ โทรฟฟ์ส์ จำกัด INNOVATIVE GLOVES Co., Ltd.

11, CHOTEVITTAYAKUL 3 ROAD, KHOHONG, HATYAI SONGKHILA 90110 FAX : [phone] TEL. [phone] MOBILE : [phone] ?1

Subject: 1993221 Amendment Nighber ; 1

Page 1 of 1

INDICATIONS FOR USE

Applicant's Name: INNQVATIVE GLOVES CQ: LTD

510 (k) Number (if known): K993221

Device Name , LATEX EXAMINATION GLOVES, PREPOWDERED

INDICATION FOR USE:

"A Medical glc ve is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient."

| | currence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use<br>(Per 21 CFR 80) 109) | OR Over-The-Counter-Use<br>(Optional Format 1-2-98) |
|------------------------------------------|-----------------------------------------------------|
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| (Division Sign-Off)<br>Division of Dental, Infection Control,<br>and General Hospital Devices | |
|-----------------------------------------------------------------------------------------------|---------|
| 510(k) Number | K993221 |