SYNTEX

K971360 · Shinemound Enterprise, Inc. · LYZ · Dec 22, 1997 · General Hospital

Device Facts

• Record ID: K971360
• Device Name: SYNTEX
• Applicant: Shinemound Enterprise, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Device Story

Powder-free vinyl examination gloves; intended as protective barrier for healthcare personnel; worn on hands to prevent cross-contamination between patient and provider; used in clinical or similar settings; disposable; non-sterile; over-the-counter use.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Vinyl material; powder-free; disposable; non-sterile; examination glove form factor.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hands to prevent cross-contamination between the personnel and the patient.

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 U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The caduceus is depicted with a modern, abstract design, consisting of flowing lines that suggest the wings and staff of the traditional symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 1997

Mr. Huan-Chung Li Vice President Shinemound enterprise, Incorporated 34 Linnell Circle Billerica, Massachusetts 01821

Re: K971360 Syntex, Powder Free Vinyl Examination Gloves Trade Name: Regulatory Class: । Product Code: LYZ Dated: November 11, 1997 November 12, 1997 Received:

Dear Mr. Li:

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 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 requirement, 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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

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Page 2 - Mr. Li

not affect any obligation you might have under sections 531 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 regulation (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 ene regulation chercred, "MrsFallig II 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

Timo hy A Ülatowski 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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Image /page/2/Picture/0 description: The image shows a logo with the letters 'S' and 'M' stacked on top of 'Inc', all enclosed within an oval shape. The 'S' is large and bold, while the 'M' is slightly smaller and positioned to the right of the 'S'. A horizontal line underlines the 'M' and extends to the right edge of the oval. The 'Inc' is in a smaller, italicized font and is located below the 'S' and 'M'.

## Shinemound Enterprise Inc.

34 LINNELL CIRCLE, BILLERICA, MASSACHUSETTS 01821 TEL [phone] FAX [phone]-9983

## Indication For Use Statement

971360 510K Number(if known):

Device Name: Powder Free Vinyl Examination Gloves

Indication For Use:

A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Truthfully Yours,

1. 1

Huan-Chung Li Vice President Shinemound Enterprise, Inc.

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

Reenge 1. Mills for ins. Jin, Ph.
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devicescurrence of CDRH, Office of Device Evaluation(ODE) 510(k) Number

OR

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use _ X

(Optional Format 1-2-96)