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FDA 510(k) Application Details - K220382
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K220382
Device Name
Polymer Patient Examination Glove
Applicant
Jiangsu Bytech Medical Supplies Co.,Ltd.
NO.88 Junshi Road, Petroleum Equipment Industrial Park
Jianyang Town, Jianhu County
Yancheng City 224700 CN
Other 510(k) Applications for this Company
Contact
Shen Hongxing
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
02/10/2022
Decision Date
04/21/2022
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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