Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K230564
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K230564
Device Name
Polymer Patient Examination Glove
Applicant
Central Medicare Sdn Bhd
PT 2609-2620, Batu 8, Jalan Changkat Jong
Teluk Intan 36000 MY
Other 510(k) Applications for this Company
Contact
Ang Shiao Ping
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
03/01/2023
Decision Date
05/23/2023
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