Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K220232
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K220232
Device Name
Polymer Patient Examination Glove
Applicant
Megine Industries Sdn Bhd
B-05-02, The Vertical Business Suites, 8,
Jalan Kerinchi, Bangsar South
Kuala Lumpur 59200 MY
Other 510(k) Applications for this Company
Contact
Benjamin Ng Soong Jing
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
01/27/2022
Decision Date
02/20/2022
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
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact