NITRILE POWDER FREE PATIENT EXAMINATION GLOVES

K993247 · Jda Intl., Inc. · LZA · Nov 5, 1999 · General Hospital

Device Facts

• Record ID: K993247
• Device Name: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
• Applicant: Jda Intl., Inc.
• 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

The medical gloves are worn on the hands of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Device Story

Nitrile powder-free patient examination gloves; worn on hands by healthcare personnel; barrier protection to prevent contamination between personnel and patients; used in clinical settings; disposable.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile rubber material; powder-free; patient examination glove; Class I device.

Indications for Use

Indicated for use by healthcare 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. Keidy Gu Vice President JDA International, Inc. 2919 E. Philadelphia Street Ontario, California 91761

Re : K993247 Nitrile Powder Free Patient Examination Trade Name: Gloves Requlatory Class: I Product Code: LZA September 21, 1999 Dated: Received: September 28, 1999

Dear Mr. Gu:

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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Gu

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 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 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,

Watrous

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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## JDA INTERNATIONA, INC.

2919 E. PHILADELPHIA STREET ONTARIO, CA 91761 TEL: [phone] FAX: [phone]

## ATTACHMENT I

Indication For Use Statement

510K number ( if known ):

Device Name: Nitrile Powder Free Patient Examination Gloves

Indications for Use:

The medical gloves are worn on the hands of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

JDA International, Inc.

Keidy Ly

Keidy Gu

( Please Do Not Write Below This Line-Continue On Another Page If Needed.)

Concurrence of CDRH, Office of Device Evaluation ( ODE )

Prescription Use

Or Over-The-Counter Use

( Optional Format 1-2-96 )

Clins S. Lin

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