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 K905172
Device Name PATIENT EXAMINATION GLOVES
Applicant
Tessile, Inc.
C/O Sandler/Travis & Rosenberg
5200 Blue Lagoon Dr.
Miami,  FL  33126
Applicant Contact ELLEN RUBIN
Correspondent
Tessile, Inc.
C/O Sandler/Travis & Rosenberg
5200 Blue Lagoon Dr.
Miami,  FL  33126
Correspondent Contact ELLEN RUBIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/13/1990
Decision Date 01/28/1991
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
-
-