FDA 510(k) Application Details - K993859

Device Classification Name Vinyl Patient Examination Glove

  More FDA Info for this Device
510(K) Number K993859
Device Name Vinyl Patient Examination Glove
Applicant SHANGHAI GLOVMAX ENTERPRISE CO.,LTD
NANKING E. RD., SEC 3
TAIPEI TW
Other 510(k) Applications for this Company
Contact MAO-SHENG LEE
Other 510(k) Applications for this Contact
Regulation Number 880.6250

  More FDA Info for this Regulation Number
Classification Product Code LYZ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 11/15/1999
Decision Date 01/12/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact