POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED

K983531 · Shanghai Antares Industries, Inc. · LYZ · Nov 30, 1998 · General Hospital

Device Facts

• Record ID: K983531
• Device Name: POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED
• Applicant: Shanghai Antares Industries, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 30, 1998
• 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 PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Device Story

Disposable nitrile medical examination glove; worn on examiner's hand or finger; provides barrier protection to prevent cross-contamination between patient and examiner during medical procedures. Used in clinical settings by healthcare professionals. Device is a passive physical barrier.

Clinical Evidence

No clinical data provided; device is a standard medical examination glove subject to general controls.

Technological Characteristics

Material: Nitrile rubber. Form factor: Disposable glove. Energy source: None. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for use as a disposable patient examination glove worn by examiners 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)

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads facing right, representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 30 1998

Mr. John Lai Sales Executive Shanqhai Antares Industries, Incorporated No. 259, Yushu Road, Cangqiao Township Songjiang County, Shanghai, CHINA, P.R.C.

K983531 Re: Powdered Nitrile Medical Examination Glove, Trade Name: White Color Requlatory Class: I Product Code: LYZ Dated: June 20, 1998 Received: October 8, 1998

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 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531

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

Page 2 - Mr. Lai

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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 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/dsma/dsmamaim.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. ula Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

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

12:01

Applicant: SHANGHAI ANTARES INDUSTRIES, INC.

SIO(k) Number (if known): * K983531

Device Name: POWDER NITRILE MEDICAL EXAMINATION GLOVE, WHITE COLOR Indications For Use:

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE

INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED) Concurence of CDRH Office of Device Evaluation (ODE)

Prescription Use OR Per 21 CFR 801 109 (Optional Format 1-2-96)

Over-The-Counter

Olin S. Lin
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

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

**PAGE ADD 3-2**