FDA 510(k) Applications Submitted by Pauline Maralit
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160471 |
02/19/2016 |
Medline Non-Surgical Isolation Gown- |
MEDLINE INDUSTRIES, INC. |
| K180696 |
03/16/2018 |
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) |
Medline Industries, Inc. |
| K190950 |
04/11/2019 |
Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown |
Medline Industries, Inc. |
| K182172 |
08/10/2018 |
Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) |
Medline Industries, Inc. |
| K172954 |
09/26/2017 |
Medline Prevention CoolZone Gown |
Medline Industries, Inc. |
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