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 K895021
Device Name MEDICARE GLOVES
Applicant
Shangrila Latex Industries Pvt. , Ltd.
Munshi Manor
20 Altamount Rd.
Bombay 400 026,  IN
Applicant Contact SANJAY MUNSHI
Correspondent
Shangrila Latex Industries Pvt. , Ltd.
Munshi Manor
20 Altamount Rd.
Bombay 400 026,  IN
Correspondent Contact SANJAY MUNSHI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/08/1989
Decision Date 02/13/1990
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
-
-