DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES

K040967 · Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd. · LYZ · Jun 16, 2004 · General Hospital

Device Facts

• Record ID: K040967
• Device Name: DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES
• Applicant: Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jun 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Disposable powder-free vinyl examination glove; worn on examiner's hand or finger; serves as protective barrier to prevent cross-contamination between patient and examiner; intended for medical use; used in clinical or healthcare settings.

Clinical Evidence

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

Technological Characteristics

Material: Vinyl (polyvinyl chloride). Form factor: Disposable, powder-free, ambidextrous glove. Energy source: None. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare. The caduceus is depicted with three lines representing the snake and staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 6 2004

Zibo Hong Wang Plastic & Rubber Products Company Limited C/O Mr. Huan-Chung Li Vice President Shinemound Enterprise, Incorporated 17A Sterling Road North Billerica, Massachusetts 01862

Re: K040967

K040907
Trade/Device Name: Disposable Powder free Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 18, 2004 Received: April 21, 2004

Dear Mr. Li:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Bection 910(t) process.
The nave reviewed your Bection of the device is substantially equivalent (for the referenced above and have determined and avires marketed predicate devices marketed in indications for use stated in the cholosaro, to regarment date of the Medical Device interstate commence prior to ridge 20, 1778, are care with the provisions of Amendments, or to devices that have been recuire approval of approval of a premarket the Federal Food, Dru;, and Cosmene Act (rice) and abertice, subject to the general
approval application (PMA). You may, therefore, market the Ast include approval application (1 Mrx). 1 ou 110), 1 ou 1109, 1 ou include controls provisions of the Act. "The gentiral of devices, good manufacturing practice, requirements for anilaars against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classince (see abo ro) into controls. Existing major regulations affecting. (PMA), it may be subject to such additional contrelations, Title 2 l, Parts 800 to 898. In the Federal your device can be found in the Code of Peachards concerning your device in the Federal Register.

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## Page 2 - Mr. Li

Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advisod that 1 DX 3 issualles of about on the your device complies with other requirements mean that ITDA has made a decemind regulations administered by other Federal agencies. of the Act of ally I ederal statutes and regarents, including, but not limited to: registration 1 ou must comply with an all also hoveng (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), labeling (21 cms (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality by seats (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) This letter will anow your o organ finding of substantial equivalence of your device to a premarket notification. "The PDF Intellige of chassification 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 desire specific advice to: your de 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division [phone] or [phone] or at its Internet address

Sincerely yours,

Chiu-Lin Liu, Ph.D.

Chiu Lin, Ph.D. 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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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K040967

Device Name: Powder Free Vinyl Examination Gloves

Indications For Use: A patient examination glove is a disposable device intended mulcations I or OSC. A patient examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ X (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia D. of A. Koons Dheding, Caking, Brann
(Division of)
David Innes

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

510(k) Number: K040967