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 Polymer Patient Examination Glove
510(k) Number K972177
Device Name POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
Applicant
Absolute Synthetic Technologies Malaysia Sdn. Bhd.
Pt 4004 Kamunting Industrial
Estate
Kamunting, Taiping, Perak,  MY 34600
Applicant Contact WOLFE BIRKIE
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact TOM BOWMAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/10/1997
Decision Date 07/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-