INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE

K993325 · Innovative Gloves Co;, Ltd. · LZA · Nov 5, 1999 · General Hospital

Device Facts

• Record ID: K993325
• Device Name: INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE
• Applicant: Innovative Gloves Co;, Ltd.
• Product Code: LZA · 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 glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.

Device Story

Nitrile latex examination gloves, powder-free; worn on hands of healthcare personnel; serves as protective barrier to prevent cross-contamination between patient and provider; used in clinical settings; disposable.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile latex material; powder-free; examination glove form factor.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hand to prevent cross-contamination between the personnel 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 Khohong, Hatyai Songkhla 90110 Thailand

Re : K993325 Trade Name: Nitrile Examination Gloves Powderfree Regulatory Class: I Product Code: LZA Dated: September 29, 1999 Received: October 4, 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 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. 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 obligation you may 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 markets production of mits 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 requlation 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

Timothy A. Ulatowski

A. 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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บริษัท อินโนเวทีฟ โกรฟส์ จำกัด INNOVATIVE GLOVES Co., Ltd.

11, CHOTEVITTAYAKUL 3 ROAD, KHOHONG, HATYAI SONGKHI A 90110 TEL. [phone] FAX : [phone] MOBILE : [phone] I

Subject: k993325 Amendment Number : 1

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INDICATIONS FOR USE

Applicant's Name: INNOVATIVE GLOVES CO: LTD

510 (k) Number (if known): K993325

Davice Name: NITRILE LATEX EXAMINATION GLOVES, POWDERFREE

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801. 109) ાર

Over-The -Counter-Use (Optional Format 1-2-98)

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