Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K213574
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K213574
Device Name
Polymer Patient Examination Glove
Applicant
Grand Work Plastic Products Co., Ltd
Donggao Industrial Zone, Zanhuang
Shijiazhuang 050000 CN
Other 510(k) Applications for this Company
Contact
Wu Yuli
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
11/10/2021
Decision Date
07/12/2022
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