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FDA 510(k) Application Details - K211927
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K211927
Device Name
Polymer Patient Examination Glove
Applicant
Fitone Latex Products Co., Ltd. Guangdong
No.5 Huitong road, Lingbei Industrial Zone, Suixi
Zhanjiang 524338 CN
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Contact
Christine Ou
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
06/22/2021
Decision Date
10/12/2021
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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