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FDA 510(k) Application Details - K970313
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K970313
Device Name
Latex Patient Examination Glove
Applicant
BESGLOVE HEALTHCARE SDN. BHD.
LOT PT 7177, BALAKONG N/V,
43300 SERI KEMBANGAN
SELANGOR MY
Other 510(k) Applications for this Company
Contact
LIM HO PENG
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
01/27/1997
Decision Date
03/11/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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