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FDA 510(k) Application Details - K220055
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K220055
Device Name
Vinyl Patient Examination Glove
Applicant
Dezhou Hengchang Medical Technology Co., Ltd
West Side of South Tiandingfeng Road, Xingtong Sub-district
Office, Linyi County,
Dezhou City 251500 CN
Other 510(k) Applications for this Company
Contact
Jing Li
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/2022
Decision Date
08/25/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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