Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K221877 |
Device Name |
Powder-Free Nitrile Examination Glove, Non-Sterile |
Applicant |
GoodGloves Industries Sdn Bhd |
PT 12678, Jalan Techvalley 2, Sendayan Techvalley |
Bandar Sri Sendayan |
Seremban,
MY
71950
|
|
Applicant Contact |
Yee Kam Lin |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 06/28/2022 |
Decision Date | 07/23/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|