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 Latex Patient Examination Glove
510(k) Number K892478
Device Name SAFETEX & SUNTEX PATIENT EXAMINATION GLOVES
Applicant
P.T. Latexindo Prautama
C/O Transcorp
40 Dogwood Dr.
Chester,  NJ  07930
Applicant Contact ROBERT S KENNEDY
Correspondent
P.T. Latexindo Prautama
C/O Transcorp
40 Dogwood Dr.
Chester,  NJ  07930
Correspondent Contact ROBERT S KENNEDY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/07/1989
Decision Date 05/08/1989
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
-
-