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 K001959
Device Name POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Applicant
Hartalega Sdn Bhd
9 Jalan Kuang Bulan Taman
Kepong Industrial Estate
Kuala Lumpur,  MY 52100
Applicant Contact NURU AISYAH KONG
Correspondent
Hartalega Sdn Bhd
9 Jalan Kuang Bulan Taman
Kepong Industrial Estate
Kuala Lumpur,  MY 52100
Correspondent Contact NURU AISYAH KONG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/27/2000
Decision Date 07/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-