Device Classification Name |
Medical Glove, Specialty
|
510(k) Number |
K191230 |
Device Name |
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves |
Applicant |
O & M Halyard, Inc. |
9120 Lockwood Blvd |
Mechanicsville,
VA
23116
|
|
Applicant Contact |
Steve Dowdlley |
Correspondent |
O & M Halyard, Inc. |
9120 Lockwood Blvd |
Mechanicsville,
VA
23116
|
|
Correspondent Contact |
Steve Dowdlley |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 05/08/2019 |
Decision Date | 11/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|