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FDA 510(k) Application Details - K170779
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K170779
Device Name
Latex Patient Examination Glove
Applicant
Terang Nusa Sdn Bhd
1 Jalan 8, Pengkalan Chepa 2,
Industrial Zone
Kota Bharu 16100 MY
Other 510(k) Applications for this Company
Contact
Robert Hill
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/15/2017
Decision Date
05/24/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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