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FDA 510(k) Application Details - K212840
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K212840
Device Name
Polymer Patient Examination Glove
Applicant
BYD Auto Industry Company Limited
No.3001,3007, Pingshan Hengping Highway,
Pingshan New District
Shenzhen 518119 CN
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Contact
Liu Jiangling
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
09/07/2021
Decision Date
12/11/2021
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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