SHANGHAI HUAMAO POWDER-FREE YELLOW VINYL EXAM GLOVES

K024154 · Shanghai Huamao Gloves Co., Ltd. · LYZ · Jan 6, 2003 · General Hospital

Device Facts

• Record ID: K024154
• Device Name: SHANGHAI HUAMAO POWDER-FREE YELLOW VINYL EXAM GLOVES
• Applicant: Shanghai Huamao Gloves Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jan 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A powderfree patient examination glove is a disposable device made of natural rubber latex or synthetic material that is intended to be worn on the hand or fingers for medical purposes to provide a barrier against poetentially infectious and other contaminants.

Device Story

Shanghai Huamao Powder-Free Yellow Vinyl Examination Gloves are disposable synthetic gloves. Device functions as a physical barrier to protect patients and healthcare personnel from infectious agents and contaminants during medical examinations. Used in clinical settings by healthcare professionals. Device is worn on hands/fingers. Benefits include reduction of cross-contamination risk during patient care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Synthetic vinyl. Form factor: Disposable examination glove. Powder-free. Regulatory Class I. Product Code: LYZ.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the hand or fingers to provide a barrier against potentially infectious and other contaminants in medical settings.

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)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features the department's name encircling a stylized emblem. The emblem consists of a symbol that resembles a stylized human form or a caduceus, which is a symbol associated with healthcare.

## FEB 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Huamao Gloves Company Limited C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K024154

Trade/Device Name: Shanghai Huamao Powder-Free Yellow Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: September 9, 2002 Received: December 17, 2002

Dear Ms. Falk:

This letter corrects our substantially equivalent letter of September 9, 2002, regarding the device name.

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.

{1}------------------------------------------------

Page 2 - Ms. Falk

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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), 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,

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

No.8 NEW INDUSTRIAL AREA, ZHU HANG ZHEN, JINSHAN COUNTY, SHANGHAI, CHINA
C/O Room C, No:201 Nanking East Rd., Sec 3, Taipei, Taiwan,
Tel:[phone] Fax:[phone]

August 30th 2002

## INDICATIONS FOR USE

Applicant: Shanghai Huamao Gloves Co., Ltd

24154 510(k) Number (if known):*

Device Name: Shanghai Huamao Gloves Co., Ltd Pouder-Free Yellow Vinyl Eyamination Glove.

Indications For Use: A powderfree patient examination glove is a disposable device made of natural rubber latex or synthetic material that is intended to be worn on the hand or fingers for medical purposes to provide a barrier against poetentially infectious and other contaminants.

Sincerely

Haich l Shich

Hsieh Yi Shi

Shanghai Huamao Gloves Co., Ltd

(Please refer to Attachment #3)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter

Per 21 CRF 801.109

(Optional Format 11-2-96)

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

Qlin S. Lin

510(k) Number: K024154