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FDA 510(k) Application Details - K212078
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K212078
Device Name
Polymer Patient Examination Glove
Applicant
Guangdong Gymda Medical Technology Co., Ltd
No.13, Quan'an Third Road, Phase 2 of High-tech Zone
Nanxiong 512400 CN
Other 510(k) Applications for this Company
Contact
Olivia Chen
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
07/02/2021
Decision Date
10/08/2021
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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