HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS)

K991969 · Pamitex Industries Sdn Bhd · LYY · Sep 9, 1999 · General Hospital

Device Facts

• Record ID: K991969
• Device Name: HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS)
• Applicant: Pamitex Industries Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Sep 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Story

Natural latex examination glove; worn on hand by healthcare personnel; provides barrier protection against patient body fluids, waste, and environmental contaminants; reduces risk of cross-contamination; features protein labeling claim of 137 micrograms or less.

Clinical Evidence

No clinical data provided; device relies on established material properties for latex examination gloves.

Technological Characteristics

Natural latex material; examination glove form factor; pre-powdered; protein content labeled at 137 micrograms or less.

Indications for Use

Indicated for use by healthcare workers and similar personnel to prevent cross-contamination between the user and the patient's body, fluids, waste, or environment.

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they also resemble a bird in flight. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 9 1999

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

K991969 Re : Health-Plus, Sanitex, Reliance Pre-Powdered Trade Name: Latex Examination Gloves with Protein Labeling Claim (137 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: June 2, 1999 Received: July 11, 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Title 21, Parts 800 to 895. Federal Regulations, 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 regulation may result in regulatory 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 obligation you might have under sections 531 through 542 of

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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 debtired in jour in jour lence of your device to a legally marketed predicate device results in a classification for your markets production of mits 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 general 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,

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

Device Name: Natural Latex Examination Glove with Protein Content labeling claim 137 micrograms or less

Indications For Use:

A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ---------------------------(Per 21 CFR 801.109)

Over The Counter Use --OR (Optional Format 1-2-95)

Qhis S. Lin

ision Sign-Off) Division of Dental, Infection Control, and General Hospital Device

510(k) Number K991969