SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES

K021000 · Shanghai Glovmax Enterprise Co.,Ltd · LZA · May 31, 2002 · General Hospital

Device Facts

• Record ID: K021000
• Device Name: SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES
• Applicant: Shanghai Glovmax Enterprise Co.,Ltd
• Product Code: LZA · General Hospital
• Decision Date: May 31, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A powdered patient examintaion glove is a disposable device made of natural nubber latex of in for Indications For USE. A powdered patient camming and is intended to be worn on the hand or fingers (s) for synthell material that bears powder to facilities don't is neemals and other conteminants.

Device Story

Disposable powdered nitrile examination glove; worn on hands/fingers by healthcare personnel; acts as protective barrier against contaminants; used in clinical settings; provides protection during patient examinations.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Powdered nitrile examination glove; disposable; non-sterile; blue color.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021000

Trade/Device Name: Shanghai Glovmax Enterprise Powdered Blue Nitrile Examination Glove Regulation Number: 880.6250 Regulation Name: Examination Glove Regulatory Class: I Product Code: LZA Dated: March 26, 2002 Received: March 28, 2002

MAY 3 1 2002

Dear Ms. Falk:

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.

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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 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,

Patricia Ciconetti for

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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## SHANGHAI GLOVMAX ENTERPRISE C

Song Jiang Industrial Zone, Che Dun Branch Zone, Rong Chang Rd No#2., Shanghai, C/O : Room B, 11F No.201, Nanking East Rd., Sec 3, Taipei, Taiwan, R.O.O Tel:[phone] Fax:[phone]

K021000

INDICATIONS FOR USE

Applicant: SHANGHAI GLOVMAX ENTERPRISE CO., LTD

510(k) Number (if known):*

Device Name: Shanghai Glovmax Enterprise Powdered Blue Nitrile Examination Glove

Indications For Use: A powdered patient examintaion glove is a disposable device made of natural nubber latex of in for Indications For USE. A powdered patient camming and is intended to be worn on the hand or fingers (s) for synthell material that bears powder to facilities don't is neemals and other conteminants.

Veich. L. Shick

Hsieh | Shi

Shanghai Glovmax Enterprise Co .,Ltd

(Piease 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 _____________________________________________________________________________________________________________________________________________________________

Per 21 CRF 801.109

Qun S. Lim

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