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 Vinyl Patient Examination Glove
510(k) Number K161390
Device Name Vinyl Exam Gloves, Powder Free, Clear
Applicant
Zibo Hongchin Plastic and Rubber Co., Ltd.
# 17 Yingxiong Rd., Zhangdian District
Zibo,  CN 255400
Applicant Contact James Ren
Correspondent
Basic Medical Industries., Inc.
805 Barrington Ave.
Ontario,  CA  91764
Correspondent Contact Sophie Hao
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/19/2016
Decision Date 12/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-