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 K013727
Device Name STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G
Applicant
Smart Glove Corp. Sdn Bhd
Lot 6487 Batu 5 3/4
Jalan Kapar
Klang Selangor,  MY 42100
Applicant Contact NG YEW SOON
Correspondent
Smart Glove Corp. Sdn Bhd
Lot 6487 Batu 5 3/4
Jalan Kapar
Klang Selangor,  MY 42100
Correspondent Contact NG YEW SOON
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/09/2001
Decision Date 12/07/2001
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
-
-