DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

K013753 · Canopus Medical Supply Co., Ltd. · LYZ · Dec 10, 2001 · General Hospital

Device Facts

• Record ID: K013753
• Device Name: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
• Applicant: Canopus Medical Supply Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

DISPOSABLE DEVICE INTENDED A PATIENT EXAMINATION GLOVES IS A FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE BRINESE

Device Story

Disposable powder-free vinyl synthetic examination gloves; worn on examiner's hand or finger; used in clinical settings to prevent cross-contamination between patient and examiner; provides physical barrier protection.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vinyl synthetic material; powder-free; disposable; patient examination glove; Class I device.

Indications for Use

Indicated for use as a patient examination glove to be worn on the examiner's hand or finger for medical purposes.

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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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Canopus Medical Supply Company Limited C/O Ms. Elizabeth Deng PM Gloves, Incorporated 13808 Magnolia Avenue Chino, California 91710

DEC 1 0 2001

Re: K013753

Trade/Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves, White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 1, 2001 Received: November 13, 2001

Dear Ms. Deng:

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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## Page 2 - Ms. Deng

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Her or any I outh all the Act's requirements, including, but not limited to: registration r ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and ilsting (21 CF R Part 807), and ity systems (QS) regulation (21 CFR Part 820); and if requirenches as bet form in adiation 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 This letter will and w you've cognized in the FDA finding of substantial equivalence of your device to 3 rotcy premained no advice 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 If you dosire opeonto and 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 nothernon (11 Cr read from the Division of Small Manufacturers, International and the receints) every 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

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The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.

INDICATIONS FOR USE CANOPUS MEDICAL SUPPLY CO., LTD. Applicant: _ Kol3753 510(k) Number (if known): * 510(k) Number (if known): * __________________________________________________________________________________________________________________________________________________ WHITE COLOR Indications For Use:

> DISPOSABLE DEVICE INTENDED A PATIENT EXAMINATION GLOVES IS A FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER,
> FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE BRINESE

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

Over-The-Counter OR Prescription Use Per 21 CFR 801.109 (Optional Format 1-2-96)

For a new submission, do NOT fill in the 510(k) number blank. #

Clair S. Lim

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