收藏网站
新闻中心
首页> 新闻中心 > 正文
FDA计划启用新的医用手套的产品分类代码和相关要求
发布时间:2010-07-28

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)

 

 

Current

 

 

Planned

 

 

Common Name

 

 

Product Code

 

 

Common Name

 

Product Code

 

Patient Examination Gloves

 

FMC

 

Non-Natural Rubber Latex, Powdered,

Patient Examination Gloves

 

FMC

 

Powder-free, Patient Examination Gloves

 

 

NPC

 

 

Non-Natural Rubber Latex, Powder-free, Patient Examination Gloves

 

NPC

 

 

Vinyl (PVC), Patient Examination Gloves

 

 

LYZ

 

Vinyl, Powdered,

Patient Examination Gloves

 

OPF

 

Vinyl, Powder-free,

Patient Examination Gloves

 

LYZ

 

Latex, Patient Examination Gloves

 

LYY

 

NR Latex, Powdered, Patient Examination Gloves

 

 

OPE

 

 

NR Latex, Powder-free, Patient Examination Gloves

 

LYY

 

Guayule Rubber, Powder-free, Patient

Examination Gloves

 

 

OIG

 

Guayle Rubber,

Powder-free, Patient Examination Gloves

 

OIG

 

Nitrile, Patient Examination Gloves

 

LZA

 

Nitrile, Powdered, Patient Examination Gloves

 

 

OPD

 

 

Nitrile, Powder-free, Patient Examination Gloves

 

 

 

LZA

 

 

Common Name

 

Product Code

 

Common Name

 

Product Code

Polychloroprene,  Patient Examination Gloves

LZA

 

Polychloroprene, Powdered, Patient Examination Gloves

 

 

OPB

 

Polychloroprene,  Patient Examination Gloves

LZA

 

Polychloroprene,

Powder-free, Patient Examination Gloves

 

 

OPC

 

Other Patient Examination Gloves

 

 

Other Patient

Examination Gloves

 

 

Radiation Attenuating Medical Gloves

 

 

 

Radiation Attenuating Medical Gloves

 

 

OPH

 

 

Specialty - Chemotherapy,

Patient Examination Gloves

 

LZC

 

Chemotherapy -“Tested for Use with Chemotherapy Drugs”

Patient Examination Gloves

 

 

OPJ

 

Specialty – Patient Examination Gloves

 

LZC

          

Specialty

Patient Examination Gloves

 

LZC

 

Finger Cot

 

LZB

 

Finger Cot

LZB

 

 

 

 

Table 1.2  Surgeon's Glove (21 CFR 878.4460)

 

Current

Planned

Common Name

Product Code

Common Name

Product Code

 

Powdered, Surgeon’s gloves

 

KGO

 

NR Latex

Powdered, Surgeon’s gloves

 

 

KGO

 

Non-NR Latex, Powdered, Surgeon’s gloves

 

OPG

 

Powder-free , Surgeon’s gloves

 

NPD

 

NR Latex

Powder-free, Surgeon’s gloves

 

 

NPD

 

Non-NR Latex Powder-free, Surgeon’s gloves

 

OPA

 

Other Surgeon’s  Gloves

 

 

Other Surgeon’s Gloves

 

 

Radiation Attenuating Medical Gloves

 

KGO

 

Radiation Attenuating Medical Gloves

 

 

OPH

 

 

Specialty - Chemotherapy,

Surgeon’s gloves

KGO

 

Chemotherapy -“Tested for Use with Chemotherapy Drugs”

Surgeon’s gloves

 

OPJ

 

Specialty Surgeon’s gloves

 

LZC

          

Specialty

Surgeon’s gloves

LZC

 

  

 

 

 

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

 

Current

Planned

Common Name

Product Code

Common Name

Product Code

 

Anaerobic

Box-gloves

 

(21 CFR 866.2120)

 

JTM

 

Anaerobic

Box-glove gloves

 

(21 CFR 866.2120)

 

JTM

 

Radiographic Protective gloves

 

(21 CFR 892.6500)

 

IWP

 

Radiographic

Protective gloves

 

(21 CFR 892.6500)

 

IWP

 

Glove Liners/Undergloves

 

(21 CFR 878.4460)

 

KGO

Glove Liners/Undergloves

 

(21 CFR 878.4460)

 

KGO

 

Surgeon’s Gloving Cream

 

(21 CFR 878.4470)

 

KGQ

Surgeon’s Gloving Cream

 

(21 CFR 878.4470)

 

KGQ

 

Surgeon’s Glove Powder

 

(21 CFR 878.4480)

 

KGP

 

Surgeon’s Glove Powde

 

(21 CFR 878.4480)

 

 

KGP

 

IRC编译整理

www.FDAChina.com