DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES

K993049 · Shanghai Antares Industries, Inc. · LYZ · Nov 19, 1999 · General Hospital

Device Facts

• Record ID: K993049
• Device Name: DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
• Applicant: Shanghai Antares Industries, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Device Story

Disposable PVC powdered synthetic examination gloves; worn on examiner's hand or finger; intended to prevent cross-contamination between patient and examiner in medical settings. Device serves as a physical barrier.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Polyvinyl chloride (PVC); powdered; disposable; form factor: examination glove.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 9 1999

Mr. John Lai Sales Executive Shanqhai Antares Industries, Inc. No. 259 Yushu Road Canqiao Township Sonqjiang County Shanghai, China, P.R.C.

Re: K993049 Disposable PVC Powdered Synthetic Trade Name: Examination Gloves Requlatory Class: I Product Code: LYZ Auqust 30, 1999 Dated: Received: September 10, 1999

Dear Mr. Lai:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Lai

the Federal Register. Please note: this response to your ene rederal notification submission does not affect any prematier nocerroacron barunder sections 531 through 542 of obligation you might have ahe Electronic Product Radiation the Act for devioes and ther Federal laws or regulations.

This letter will allow you to begin marketing your device as Inis icceer w=== arrow formarket notification. The FDA described in your 515\n privalence of your device to a legally Finding of bubbeanslasics in a classification for your marketed predicate arits your device to proceed to the market.

If you desire specific advice for your device on our labeling re you debire opeone and additionally 809.10 for in reguladiagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Dromocion and advoreze at [phone]. Also, please note ene orrios or centitled, "Misbranding by reference to che regulacion chorologics, 21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/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

Enclosure

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- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use r The information, data and labeling claims in the entire the 510(k) submission muse support agree with the Indications for Use statement.
## INDICATIONS FOR USE

Applicant: ___________________________________________________________________________________________________________________________________________________________________ SHANGHAI ANTARES INDUSTRIES, INC. 510(k) Number (if known): * ___

Device Name: _ DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES Indications For Use:

> A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER HAND OR FINGER 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 OR Over-The-Counter Per 21 CFR 801.109

(Optional Format 1-2-96)

- * For a new submission, do NOT fill in the 510(k) number blank.
Chia S. Lin

്ലബം of Dental, Infection Cont and General Hospital 510(k) Number