POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)

K992497 · Kossan Latex Industries(M)Sdn Bhd · LZA · Aug 25, 1999 · General Hospital

Device Facts

• Record ID: K992497
• Device Name: POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
• Applicant: Kossan Latex Industries(M)Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Aug 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Disposable nitrile patient examination glove; worn on examiner's hand or finger; provides barrier protection to prevent cross-contamination between patient and examiner during medical procedures. Used in clinical settings by healthcare professionals. Device is non-sterile, powdered, and available in blue or white (non-colored) variants.

Clinical Evidence

bench testing only

Technological Characteristics

Nitrile material; powdered; disposable; non-sterile; blue or white color options.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1999

Mr. Lim Kwan Hwa Executive Director Kossan Latex Industries (M) SDN. BHD. Lot 16632, 5¼ Miles, Jalan Meru, 41050 Klang Selangor Darul Ehsan, MALAYSIA

Re: K992497 Powdered Nitrile Examination Glove, Blue or Trade Name: White (Non-Colored) Regulatory Class: I Product Code: LZA Dated: July 20, 1999 Received: July 26, 1999

Dear Mr. Lim Kwan Hwa:

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 legally marketed predicate 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2 - Mr. Lim Kwan Hwa

Please note: concerning your device in the Federal Register. 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 assoirson 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" (21CFR 807.97). Other genera 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo thy A. Ulatows 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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Section 3

510 (K) Number (if known) : K992497

Device Name : Pre powdered Nitrile Patient Fy

Device Name

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: Pre-powdered Nitrile Patient Examination Glove. LUE AND WHITE (NON-GLORED)

Indications For Use

A 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ( Per 21 CFR 801. 109 ) OR

Over-The-Counter Use

( Optional Format 1-2-96 )

IN (1) Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number KG92497

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