HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE

K992299 · Pamitex Industries Sdn Bhd · LZA · Aug 23, 1999 · General Hospital

Device Facts

• Record ID: K992299
• Device Name: HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
• Applicant: Pamitex Industries Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Aug 23, 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 examiners.

Device Story

Device is a pre-powdered nitrile patient examination glove. Used by healthcare professionals in clinical settings to provide a protective barrier on hands or fingers. Prevents cross-contamination between patient and examiner during medical examinations. Disposable design.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Nitrile rubber. Form factor: Disposable glove. Type: Pre-powdered. Regulatory Class: I. Product Code: LZA.

Indications for Use

Indicated for use as a disposable medical device 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 3 1999

Mr. Said Awang Product Development & Technical QA Pamitex Industries SDN. BHD. 2½ Miles, Jalan Rasah 70300 Seremban, Negeri Darul Sembilan Khusus, Malaysia

K992299 Re: Health-Plus, Sanitex, Relance Pre-Powdered Trade Name: Nitrile Examinstion Gloves Regulatory Class: I Product Code: LZA Dated: July 02, 1999 Received: July 08, 1999

Dear Mr. Awang:

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 qeneral 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) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 obliqation 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.

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Page 2 - Mr. Awang

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 Other general information on your responsibilities CFR 807.97). 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.hfml".

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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K992299

SIO(K) NUMBER (IF KNOWN) :

Pre-Powdered Nitrile Examination Glove DEVICE NAME:

INDICATIONS FOR USE:

发

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 examiners.

(PLEASE DO NOT RRITE BELOW THIS LINE-CONTINUE ON ANOTHER I IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODB

Prescription Use (Per 21 CFR 801.109)

: ,

OR

Over-The-Counter-(Optional Form:

Clim S. lin

(Division Sign-Off) Division of Dental and General Ho 510(k) Number