NITRILE LATEX POWDERED EXAMINATION GLOVE

K983816 · Top Glove Sdn. Bhd. · LZA · Dec 4, 1998 · General Hospital

Device Facts

• Record ID: K983816
• Device Name: NITRILE LATEX POWDERED EXAMINATION GLOVE
• Applicant: Top Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner .

Device Story

Powdered nitrile examination glove; disposable; worn on examiner's hand. Primary function: barrier protection to prevent cross-contamination between patient and examiner. Used in clinical/medical settings. Device acts as physical barrier; no electronic or algorithmic components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile material; powdered; disposable; examination glove form factor.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1998 DEC

Mr. T. S. Puon Factory Manager Top Glove Sdn. Bhd. Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru 41050 Klang, Selangor D.E. MALAYSIA

K983816 Re : Nitrile Examination Glove, Powdered Trade Name: Requlatory Class: I Product Code: LZA Dated: October 21, 1998 October 29, 1998 Received:

Dear Mr. Puon:

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 abe beacudin 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. ਦੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (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. 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

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Page 2 - Mr. Puon

through 542 of the Act for devices under the Electronic enrough 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 as 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

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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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The Information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.

## INDICATIONS FOR USE

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Applicant; __ TOP GLOVE SDN. BHD.

510(k) Number (if known): -----

Device Name: ____ POWDERED NITRILE EXAMINATION GLOVE

Indications For Use;

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner .

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

Concurrence of CDRH Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> <div>(Division Sign-Off)</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> <div>510(k) Number <span style="text-decoration: underline;">K983816</span></div> |
|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Prescription Use | OR | Over-The-Counter |
|----------------------------------------------------------------------|----|----------------------------------------------------------------------------|
| Per 21 CFR 801.109 <span style="text-decoration: underline;"></span> | | (Optional Format 1-2-96) <span style="text-decoration: underline;"></span> |

§ For a new submission, do NOT fill in the 510(k) number blank.

* For a new submission, do NO'l' fill in the 510(k) number blank.

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