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FDA 510(k) Application Details - K170136
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K170136
Device Name
Polymer Patient Examination Glove
Applicant
SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD
338 HUAQING DRIVE
QIXIN CHEMICAL INDUSTRY ZONE
QINGZHOU 255000 CN
Other 510(k) Applications for this Company
Contact
KEN LU
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/17/2017
Decision Date
08/25/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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