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FDA 510(k) Application Details - K211264
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K211264
Device Name
Polymer Patient Examination Glove
Applicant
Shenzhen Shiqiao Science and Technology Co. LTD
Unit 2105 ,Tower D, Galaxy World phase II, Minle community
Minzhi Street
Shenzhen 518000 CN
Other 510(k) Applications for this Company
Contact
Mikki Wan
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
04/26/2021
Decision Date
07/30/2021
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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