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U.S. Department of Health and Human Services

Medical Devices

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Medical Glove Guidance Manual

PDF Printer Version

Document issued on January 22, 2008

This document supersedes Guidance for Medical Gloves – A Workshop Manual, September 1996.

For questions regarding this document contact John Stigi at 301-796-5848 or via email at john.stigi@fda.hhs.gov.

CDRH Logo

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Office of Communication, Education and Radiation Programs
Division of Small Manufacturers, International and Consumer Assistance 

Preface

Public Comment

Written comments and suggestions may be submitted at any time for Agency consideration to:

Director, Division of Small Manufacturers, International and Consumer Assistance
Center for Devices and Radiological Health
Food and Drug Administration,
10903 New Hampshire Avenue

Silver Spring, MD 20993

Alternatively, electronic comments may be submitted to dsmica@fda.hhs.gov.

When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number (1661) to identify the guidance you are requesting.

Guidance for Industry and FDA Staff  

Medical Glove Guidance Manual

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

Introduction

This manual provides FDA’s recommendations for Premarket Notification (510(k)) submissions for medical gloves. It also provides our recommendations on how to comply with the Quality System regulation (21 CFR part 820). Previous revisions of this manual were entitled “Guidance for Medical Gloves: A Workshop Manual.” This edition, the “Medical Glove Guidance Manual” (manual), supersedes all earlier revisions and explains FDA’s current thinking on the requirements and recommendations for medical gloves that are marketed in the United States (U.S.).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

The Least Burdensome Approach

The issues identified in this guidance document represent those that we believe should be addressed before your device can be marketed. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. We also considered the burden that may be incurred in your attempt to follow the guidance and address the issues we have identified. We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. If, however, you believe that there is a less burdensome way to address the issues, you should follow the procedures outlined in the “A Suggested Approach to Resolving Least Burdensome Issues” document.