MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE

K013261 · Shanghai Motex Healthcare Co., Ltd. · LZA · Nov 29, 2001 · General Hospital

Device Facts

• Record ID: K013261
• Device Name: MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE
• Applicant: Shanghai Motex Healthcare Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination glove; worn on hands/fingers by healthcare personnel; acts as physical barrier to prevent cross-contamination between patient and examiner; intended for medical purposes; non-sterile, powder-free synthetic material.

Clinical Evidence

No clinical data provided; device is a standard patient examination glove.

Technological Characteristics

Synthetic nitrile material; powder-free; disposable; form-fitting glove design; non-sterile.

Indications for Use

Indicated for use as a disposable, synthetic, powder-free glove worn by medical 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

Shanghai Motex Healthcare Company Limited C/O Mr. Tzu-Wei Li Center for Measurement Standards of Industrial Bldg. 16, 321 Kuang Fu Road, Section 2 Hsinchu, TAIWAN 30042, R.O.C

NOV 2 9 2001

Re: K013261

Trade/Device Name: Motex Nitrile Examination Gloves Powder-Free Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: November 7, 2001 Received: November 20, 2001

Dear Mr. Li:

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.

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

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of the Act or any Federal statutes and regulations administered by other Federal agencies. or the ret or any 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,

Timothy A. Ulatowski

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

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K013261

## INDICATIONS FOR USE STATEMENT

Applicant: 510(k) Number : __ (New Applicant) ___________________________________________________________________________________________________________________________________________ Device Name: Nitrile Powder-Free Examination Gloves

Indication For Use :

Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

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

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter

×

(Optional Format 1-2-96)

Olin S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 6 ? O(k) Number .