Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K151836
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K151836
Device Name
Polymer Patient Examination Glove
Applicant
HARTALEGA NGC SDN BHD
NO. 1, PERSIARAN TANJUNG, LOT PT4330
KAWASAN PERINDUSTRIAN TANJUNG, JALAN B20,
SEPANG 64000 MY
Other 510(k) Applications for this Company
Contact
KUAN MUN LEONG
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
07/06/2015
Decision Date
10/21/2015
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact