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FDA 510(k) Application Details - K212922
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K212922
Device Name
Polymer Patient Examination Glove
Applicant
HSK Medical Apparatus Foshan China Co. LTD
Shitang Road, Shishan Town, Nanhai District
Foshan 528234 CN
Other 510(k) Applications for this Company
Contact
Zhao Zhongheng
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
09/14/2021
Decision Date
12/10/2021
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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