Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K213729
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K213729
Device Name
Polymer Patient Examination Glove
Applicant
Clover Glove Company Limited
1999/8 District Sriwara Village, Ladphrao 94 (Punjamit)
Sriwara Rd, Plabphla
Wang Thong Lang 10240 TH
Other 510(k) Applications for this Company
Contact
Pongsin Pongwachirint
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
11/26/2021
Decision Date
03/26/2022
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