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 Vinyl Patient Examination Glove
510(k) Number K093727
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR
Applicant
Zibo Bolin Gloves Co., Ltd.
Rm. 1606 Bldg. 1 Jian Xiangyuan
Bei Si Huan Zhong Rd., Hai Di
Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Zibo Bolin Gloves Co., Ltd.
Rm. 1606 Bldg. 1 Jian Xiangyuan
Bei Si Huan Zhong Rd., Hai Di
Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/03/2009
Decision Date 02/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-