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 K001836
Device Name NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
Applicant
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434 -9550
Applicant Contact JANNA P TUCKER
Correspondent
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434 -9550
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/16/2000
Decision Date 07/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-