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 K000584
Device Name POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD.
198 AVENUE DE D'EMERALD
SPARKS,  NV  89434
Applicant Contact JANNA P TUCKER
Correspondent
SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD.
198 AVENUE DE D'EMERALD
SPARKS,  NV  89434
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/22/2000
Decision Date 04/12/2000
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
-
-