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 Surgeon'S Gloves
510(k) Number K021065
Device Name PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
Applicant
Primus Gloves Private , Ltd.
14 A, Cochin Special Economic
Zone
Kakkanad, Cochin, Kerala,  IN 682 030
Applicant Contact JOSEPH J E PEREIRA
Correspondent
Primus Gloves Private , Ltd.
14 A, Cochin Special Economic
Zone
Kakkanad, Cochin, Kerala,  IN 682 030
Correspondent Contact JOSEPH J E PEREIRA
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/02/2002
Decision Date 05/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-