Device Classification Name |
surgeon's gloves
|
510(k) Number |
K190241 |
Device Name |
Sterile Latex Surgical Glove, Powder Free |
Applicant |
Careglove Global Sdn Bhd |
Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In |
Seremban,
MY
70450
|
|
Applicant Contact |
Lim Kwee Shyan |
Correspondent |
Careglove Global Sdn Bhd |
Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In |
Seremban,
MY
70450
|
|
Correspondent Contact |
Lim Kwee Shyan |
Regulation Number | 878.4460
|
Classification Product Code |
|
Date Received | 02/06/2019 |
Decision Date | 12/30/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|