MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)

K993127 · Glovesworld Industries Sdn. Bhd. · LZA · Dec 2, 1999 · General Hospital

Device Facts

• Record ID: K993127
• Device Name: MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)
• Applicant: Glovesworld Industries Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 2, 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 to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Nitrile patient examination glove; disposable; powder-free. Worn by healthcare professionals during patient examinations to provide a protective barrier against contamination. Device functions as a physical barrier; no electronic or mechanical components. Used in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and compliance with general controls for Class I medical devices.

Technological Characteristics

Nitrile rubber material; powder-free; disposable; non-sterile; physical barrier form factor.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

Mr. Bien Long Nien Glovesworld Industries Sdn. Bhd. Lot P.T. 153, Kawasan Perusahaan Beranang, Mukim Beranang, Selangor, D.E., Malaysia

Re : K993127 Trade Name: Multi-Comfort Nitrile Examination Gloves, (Powder Free) Requlatory Class: I Product Code: LZA November 5, 1999 Dated: Received: November 15, 1999

Dear Mr. Nien:

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 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) requlation (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 requlatory 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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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 requlations.

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 regulation (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 qeneral 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,

Patricia Cuesta/for

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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- Indications for Uses: Include the following or equivalent "Indications For Use" page that 3.0 contains the applicants name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indication for use" statement.
- * For a new submission, do NOT fill in the 510(k) number blank.

## INDICATIONS FOR USE

Applicant: GLOVESWORLD INDUSTRIES SDN. BHD.

510(k) Number (if known): *

Device Name: Nitrile Patient Examination Gloves (Powder Free)

Indications For Use:

A Patient Examination Glove is a disposable device intended for medical purposes that is to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

Concurrent of CDRH Office of Device Evaluation (ODE)

Qais Sidin

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

Prescription Use Per 21 CFR 801.109 Over-The-Counter