FDA 510(k) Application Details - K010803

Device Classification Name Latex Patient Examination Glove

  More FDA Info for this Device
510(K) Number K010803
Device Name Latex Patient Examination Glove
Applicant HWA TEH INDUSTRIAL SDN. BHD.
LOT 187, SUNGAI DAHAR
BATANG BERJUNTAI 45600 MY
Other 510(k) Applications for this Company
Contact ABDUL HALIM ARSHAD
Other 510(k) Applications for this Contact
Regulation Number 880.6250

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

  More FDA Info for this Product Code
Date Received 03/16/2001
Decision Date 05/11/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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