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 K992922
Device Name SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
Applicant
Shijiazhuang Hongray Plastic Products Co., Ltd.
# 135 Xin-Hua W. Rd.
Shijiazhuang,  CN 050081
Applicant Contact GUI-XI LIU
Correspondent
Shijiazhuang Hongray Plastic Products Co., Ltd.
# 135 Xin-Hua W. Rd.
Shijiazhuang,  CN 050081
Correspondent Contact GUI-XI LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/30/1999
Decision Date 10/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-