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 K130800
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
KAIXUAN PLASTIC CO., LTD.
RM.1606 BLDG.1 JIANXIANG YUAN NO.209
BEI SI HUAN ZHONG ROAD
HAIDIAN DISTRICT, BEIJING,  CN 1000083
Applicant Contact CHU XIAOAN
Correspondent
KAIXUAN PLASTIC CO., LTD.
RM.1606 BLDG.1 JIANXIANG YUAN NO.209
BEI SI HUAN ZHONG ROAD
HAIDIAN DISTRICT, BEIJING,  CN 1000083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/22/2013
Decision Date 02/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-