Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Polymer Patient Examination Glove
510(k) Number K250496
Device Name Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
Applicant
Zibo Shengkun Chemical Industry Co., Ltd.
Lot 6, # 21 Qingtian Rd.
Qilu Chemical Industrial Park
Zibo,  CN 255414
Applicant Contact Yanfeng Zhang
Correspondent
Zibo Shengkun Chemical Industry Co., Ltd.
Lot 6, # 21 Qingtian Rd.
Qilu Chemical Industrial Park
Zibo,  CN 255414
Correspondent Contact Yanfeng Zhang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/20/2025
Decision Date 07/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-