UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)

K982611 · Uniject Gloves Pcl · LYY · Nov 2, 1998 · General Hospital

Device Facts

• Record ID: K982611
• Device Name: UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)
• Applicant: Uniject Gloves Pcl
• Product Code: LYY · General Hospital
• Decision Date: Nov 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

An Examination Gloves 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

Device Story

Uniject Latex Examination Gloves (Powder-Free) are disposable medical gloves designed for use by healthcare professionals during patient examinations. The gloves act as a physical barrier to prevent cross-contamination between the examiner and the patient. They are intended for general clinical use in medical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable latex examination gloves; powder-free; Class I medical device; Product Code LYY.

Indications for Use

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

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998 NOV

Uniject Gloves Ltd. C/O Dr. Syed Z. Baber, Sr. International Suppliers, Incorporated P.O. Box 1035 Chalmette, Louisiana 70044

Re : K982611 Trade Name: Uniject Latex Examination Gloves (Powder-Free) Requlatory Class: I Product Code: LYY October 6, 1998 Dated: Received: October 7, 1998

Dear Dr. Baber:

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 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 Requlations, Title 21, Parts 800 to 895. ਕਿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Dr. Baber

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 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 ene regulation cheroids, "MEFR 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

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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## INDICATIONS FOR USE

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Applicant

3.0

UNIJECT GLOVES LTD. JEBEL ALL, DUBAI (U. A.E) 9826

510(K) Number (if known)

Device Name

UNIJECT EXAMINATION (H.UVES POWDER FREE

An Examination Gloves 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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDKH Office of Device Evaluation (ODE) Prescription Use ............................................................................................................................................................. OR Over-The-Counter .. Per 21 CFR 801.109 (Division . Division of Denet, Infection Control, (Optional Format 1-2-96)
and General Hospital Devices and General Hospital Devices 510(k) Number

4.0 Glove Proprietary or Trade Name :

UNDECT EXAMINATION GLOVES