VINYL EXAMINATION GLOVES STERILE POWEDERED

K020044 · Primus Gloves Private , Ltd. · LYZ · Feb 26, 2002 · General Hospital

Device Facts

• Record ID: K020044
• Device Name: VINYL EXAMINATION GLOVES STERILE POWEDERED
• Applicant: Primus Gloves Private , Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Feb 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A Vinyl examination glove sterile powdered is a disposable device made of polyvinyl chloride paste resin that bears powder to facilitate donning and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Device Story

Vinyl examination glove; sterile; powdered; disposable. Material: polyvinyl chloride paste resin. Function: barrier against infectious materials and contaminants. Use: worn on hands by healthcare personnel in clinical settings. Benefit: protection for patient and provider during medical examinations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on device classification and intended use.

Technological Characteristics

Material: polyvinyl chloride paste resin. Form: sterile, powdered examination glove. Energy source: none. Connectivity: none. Software: none.

Indications for Use

Indicated for use as a disposable, sterile, powdered, polyvinyl chloride examination glove worn on the hands by healthcare personnel to provide a barrier against potentially infectious materials and contaminants.

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 shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

Mr. Joseph J. E. Pereira Primus Gloves Private Limited Plot No:14-A Cochin Special Economic Zone Kakkanad, Kochi, Kerala, INDIA

Re: K020044

Trade/Device Name: Vinyl Examination Gloves, Sterile Powdered Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: December 29, 2001 Received: January 7, 2002

Dear Mr. Pereira:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 12) your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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

Page 2 - Mr. Pereira

of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

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

Enclosure

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

Primus

## PRIMUS GLOVES (P) Limited

European Office:

Plot No. 14-A, Cochin Special Economic Zone, Goldberg 16, D-23562, t No. 14-A, Cochin Special Economia, India Lubeck, Germany
Kakkanad, Cochin - 682 030, Kerala, India Lubeck, Germany Kakkanao, Cochin - Boz 650, Fax: [phone] Tel + 49 - 451 - 5823540
Tel: [phone], 423530, Fax: [phone] Tel + 49 - 451 - 5823540 Tel: [phone], 423550, Pax: 31-404 42 1000 Fax: + 49 - 451 - 5823541
Email : [e-mail]; [e-mail] Fax: + 49 - 451 - 5823541
Email : primusgl@vsnl.c l, primusgloves.com Email: [e-mail]

## ENCLOSURE-II

KO20044

## INDICATIONS FOR USE

:

:

APPLICANT

PRIMUS GLOVES PRIVATE LTD

510 (K) NO

DEVICE NAME

VINYL EXAMINATION GLOVES – STERILE POWDERED

## INDICATIONS FOR USE.

A Vinyl examination glove sterile powdered is a disposable device made of
er and and interest in that beers, nowder, to, facilitate donning a A Vinyl examination glove stem that bears powder to facilitate donning and is
polyvinyl chloride paste resin that bears powder to facilitate donning and is intended to be worn on the hands, for medical purposes to provide a barrier
intended to be worn on the hands, for medical purposes to provide a barrier
s. intended to be world on the manas, 100 m.
against potentially infectious materials and other contaminants.

Susan Rupp

(Division Sign-Off) Division of Dental, Infection Control, േദ General Hospital Devices പച്ച F100k) Number _