The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Sensicare Sterile Powder-free Polymer Coated Polyisoprene Surgical Glove, With Aloe Vera (tested Of Use With Chemotherapy Drugs) -natural Color.
| Device ID | K150238 |
| 510k Number | K150238 |
| Device Name: | SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, With Aloe Vera (Tested Of Use With Chemotherapy Drugs) -Natural Color |
| Classification | Surgeon's Gloves |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Contact | Claire Wellinghoff |
| Correspondent | Claire Wellinghoff MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-02 |
| Decision Date | 2015-11-27 |
| Summary: | summary |