ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES

K012499 · Shanghai Antares Industries, Inc. · LYZ · Oct 16, 2001 · General Hospital

Device Facts

• Record ID: K012499
• Device Name: ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
• Applicant: Shanghai Antares Industries, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Oct 16, 2001
• 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 PURPOSE THAT IS WORN ON THE EXANINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Device Story

Environ-NP Powder Free Synthetic Vinyl Examination Gloves are disposable, non-sterile gloves designed for medical examination purposes. Worn by healthcare professionals on hands or fingers to provide a barrier against cross-contamination between the patient and the examiner. Used in clinical or medical settings. Device functions as a physical barrier; no electronic or active components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Synthetic vinyl material; powder-free; disposable; non-sterile; physical barrier form factor.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2001

Mr. John Lai Sales Executive Shanghai Antares Industries, Incorporated 259 Yushu Road Cangqiao Township Songjiang Shanghai, CHINA

Re: K012499

Trade/Device Name: Environ-NP Powder Free Synthetic Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: February 7, 2001 Received: August 3, 2001

Dear Mr. Lai:

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

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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,

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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K012499

- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the SIO(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE Applicant: SHANGHAI ANTARES INDUSTRIES, INC. 510(k) Number (if known): * . K012339 Environ-NF DISPOSABLE SYNTHETIC VINYL EXAM GLOVE, POWDER FREE Device Name: Indications For Use:

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXANINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

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

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

- For a now submission, do NOT fill in the 510(k) number blank.
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Division of Dental, Infection Control. Division of General Hospital ano (k) Number

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