Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K213016
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K213016
Device Name
Polymer Patient Examination Glove
Applicant
Phu Duc Huy Production Trading Services Corporation
Hamlet 8, Luong Hoa Commune
Ben Luc District 82000 VN
Other 510(k) Applications for this Company
Contact
Tran Xuan Kiem
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
09/20/2021
Decision Date
12/28/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact