Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K212847 |
Device Name |
Penta Glove |
Applicant |
Pentavest Holdings Sdn Bhd |
No. 9574-9578, Jalan PTB 2 , Kawasan Perindustrian Tangga, |
Batu,
MY
76400
|
|
Applicant Contact |
Teng Boon Joo |
Correspondent |
Liberty Management Group Ltd. |
75 Executive Dr. STE 114 |
Aurora,
IL
60504
|
|
Correspondent Contact |
Manoj Zacharias |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 09/07/2021 |
Decision Date | 01/06/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|