HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)

K993093 · Pamitex Industries Sdn Bhd · LYY · Oct 29, 1999 · General Hospital

Device Facts

• Record ID: K993093
• Device Name: HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
• Applicant: Pamitex Industries Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Oct 29, 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 purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.

Device Story

Disposable powder-free latex examination glove; worn by healthcare providers on hands or fingers; acts as a physical barrier to prevent cross-contamination between patient and examiner during medical procedures. Device features a labeling claim of 50 micrograms or less of total water-extractable protein per gram to reduce potential for latex protein sensitization.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Latex. Form factor: Disposable examination glove. Feature: Powder-free with low protein content (≤ 50 micrograms/gram).

Indications for Use

Indicated for use as a disposable medical glove worn by examiners on hands or fingers to prevent cross-contamination between patients and examiners.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three wavy lines below it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 1999

Mr. Said Awanq Product Development and Technical QA Pamitex Industries Sdn. Bhd. Batu 2½, Jalan Rasah 70300 Seremban, Negeri Sembilan Darul Khusus, MALAYSIA

Re : K993093 Trade Name: Powder-Free Latex Examination Glove With Labeling Claim of 50 micrograms or less of total extractable protein per gram Regulatory Class: I Product Code: LYY Dated: September 7, 1999 Received: September 16, 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 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 Regulations, Title 21, Parts 800 to 895. 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

{1}------------------------------------------------

Page 2 - Mr. Awang

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 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 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 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

Timothy A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known): K993093

Device Name: Powder-free Latex Examination Glove with Labeling Claim of 50 micrograms or less of total water extractable protein per gram.

Indication For Use:

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.

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

OR

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

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

Olin S. Lin

ision Sign-Off) ു വ് Dental, Infection 1-10(k) Number