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FDA计划启用新的医用手套的产品分类代码和相关要求

FDA计划近期启用新的医用手套产品分类代码，影响到美国进口该类产品的进口申报文件准备，并计划对所有已经批准的各类510(K)手套的制造商颁发更新了产品分类代码的510(K)批准函；在FDA批准新代码和更新所有相关510(K)批准函后, 新产品分类代码将替代旧代码；

受影响的医用手套包含检查手套，手术手套和其他各类型手套等；

July 27, 2010

Dear Medical Glove Manufacturer,

This letter is to advise you that the United States Food and Drug Administration (USFDA) is in the process of updating the Product Codes for Medical Gloves to provide greater specificity regarding glove type. The Product Codes are found in our classification database with each premarket notification 510(k) www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm and are noted in the reference section of all 510(k) letters of substantial equivalence since at least 1990.  The variety of Medical Gloves has expanded greatly over the 25 years that I have assisted the glove industry, from the standard powdered latex glove to powder-free, synthetic, colored, etc.  The new product codes will allow USFDA to distinguish the significant types of gloves marketed in the United States (U.S.) by a manufacturer/510(k) holder, and allow us to better serve the glove industry and other stakeholders.

What you should do at this time:

When preparing import paperwork, including your USFDA Listing, you must continue to reference the “Current Product Codes” that are found on your 510(k) letter of substantial equivalence and noted at the left hand column in the tables below to avoid delays at the port of entry into the U.S.  Do not use the “Planned Common Name and Planned Product Code” on any FDA submissions until the codes have been finalized, and you have been notified by USFDA by receipt of a revised letter of substantial equivalence for your 510(k)s.

Timing of Change

USFDA will advise the Official Correspondents or U.S. Agents of all firms that have listed Medical Gloves when the Planned Product Codes become effective.

USFDA is reviewing all Medical Glove 510(k)s cleared by the agency and updating the associated Product Codes.  After all Medical Glove 510(k)s on record are reviewed, revised Substantial Equivalence (SE) letters will be issued to the 510(k) submitters.  The updated Product Codes will only be put into effect after the USFDA issues these revised SE letters that contain the updated Product Codes. 

Need Further Clarifications?

If you need further clarification on this issue or any other type of assistance in complying with USFDA medical device regulations, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA), by email at DSMICA@FDA.HHS.GOV 

Sincerely yours, 

John Stigi

Director

Division of Small Manufacturers, International and Consumer Assistance

Office of Communication, Education and Radiation Programs

Center for Devices and Radiological Health

U.S. Food and Drug Administration

Table 1.1 Patient Examination Glove (21 CFR 880.6250)

Table 1.2  Surgeon's Glove (21 CFR 878.4460)

Table 1.3 Other Medical Gloves (that are not Patient Examination or Surgeon’s gloves) and Accessories.  See Common Name for 21 CFR number.

IRC编译整理

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