LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES

K982114 · M/S Midland Latex Products , Ltd. · LYY · Jan 21, 1999 · General Hospital

Device Facts

• Record ID: K982114
• Device Name: LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES
• Applicant: M/S Midland Latex Products , Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Jan 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Story

The device consists of powder-free latex examination gloves. These gloves are worn by healthcare personnel to provide a protective barrier, preventing cross-contamination between the clinician and the patient. The gloves feature a protein content labeling claim of 50 micrograms or less, intended to reduce the risk of latex-related allergic reactions. They are intended for over-the-counter use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powder-free latex examination glove. Features protein content labeling claim of 50 micrograms or less.

Indications for Use

Indicated for use by health care and similar personnel as a protective barrier to prevent cross-contamination between the wearer and the patient.

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/2 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" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

JAN 2 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Midland Latex Products Ltd. M/ ਫ C/O Mr. Anil Segat Preventive Care, Incorporated 915 Blue Gentian Road, Suite 1 Eagan, Minnesota 55121 USA

K982114 Re : LOPRO, AVT Exam-Perfect, Guardian, Millenium Trade Name: Fusion S2 & Health Tec Powder-Free Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less) Requlatory Class: । Product Code: LYY Dated: December 24, 1998 December 30, 1998 Received:

Dear Mr. Segat:

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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Segat

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/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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## MIDLAND LATEX PRODUCTS LTD.

Plot No. 14C, Cochin Export Processing Zone Kakkanad, Cochin 682 030, INDIA. Tel: [phone], 422514 Fax: [phone] Regd. Office: 22 Marshalls Road, Egmore, Madras 600 008 (Formerly known as AVT RUBBER PRODUCTS LTD.)

K982114

ENCLOSURE l I I

い

## T M D T C B I T G R F S . E E ਜ 2 E

AFFLICANT MIDLAND LATEX FRODUCTS LTD; :

SIQ(K) NG : NEW APPLICATION

: LOPRP, AVT, EXAM-PERFECT, GUARDIAN, MILLENIUM FUS DEVICE NAME S2 & HEALTH TEC - Powder Free Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less)

INDICATIONS FOR USE =

A medical glove is worn on the hand of

health care and similar personnel to prevent contamination

between health care personnel and the patient.

## Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter X

Per 21 CFR 801.109

Olin S. Lin (optional Format 1-2-96)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

CONFIDENTIAL- DO NOT COPY

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