LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX

K031386 · Lalan Gloves (Pvt) , Ltd. · LYY · Oct 6, 2003 · General Hospital

Device Facts

• Record ID: K031386
• Device Name: LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX
• Applicant: Lalan Gloves (Pvt) , Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Oct 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A POWDER FREE PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX OR SYNTHETIC MATERIAL THAT MAY BEAR A TRACE AMOUNT OF GLOVE POWDER IS INTENDED TO BE WORN ON THE HAND OR FINGER (S) FOR MEDICAL PURPOSE TO PROVIDE A BARRIER AGAINST POTENTIALLY INFECTIOUS MATERIAL AND OTHER CONTAMINANTS.

Device Story

Disposable patient examination glove; natural rubber latex; worn on hands/fingers; provides barrier against infectious materials/contaminants; used in clinical settings by healthcare personnel.

Clinical Evidence

Bench testing only.

Technological Characteristics

Natural rubber latex; disposable; powder-free; patient examination glove.

Indications for Use

Indicated for use as a disposable barrier on hands or fingers to protect against infectious materials and contaminants during medical examinations.

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 is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 6 2003

Mr. Upul Gunasinghe Quality Assurance Manager Lalan Glove (PVT) Limited Block B. Bepz Biyagama, Sri Lanka T.P. 009414-65802

Re: K031386

Trade/Device Name: Glove Powder Free Patient Examination, Latex Regulation Number: 880:6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 16, 2003 Received: August 25, 2003

Dear Mr. Gunasinghe:

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 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.

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Page 2 - Mr. Gunasinghe

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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Kuonen

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Sample Format

## INDICATIONS FOR USE

: LALAN GLOVES (PVT) LTD. Applicant's Name

510(k) Number (if known)* : K031386

: GLOVE, POWDER FREE, PATIENT EXAMINATION, LATEX Device Name

Indications For Use :

A POWDER FREE PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX OR SYNTHETIC MATERIAL THAT MAY BEAR A TRACE AMOUNT OF GLOVE POWDER IS INTENDED TO BE WORN ON THE HAND OR FINGER (S) FOR MEDICAL PURPOSE TO PROVIDE A BARRIER AGAINST POTENTIALLY INFECTIOUS MATERIAL AND OTHER CONTAMINANTS.

Qhin S. Lin

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Dev

510(k) Number: K031386