The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Signature Latex And Signature Latex Micro, Powder-free, Surgical Glove, Tested For Use With Chemotherapy Drugs With A Protein Content Label Claim Of.
| Device ID | K202668 |
| 510k Number | K202668 |
| Device Name: | Signature Latex And Signature Latex Micro, Powder-Free, Surgical Glove, Tested For Use With Chemotherapy Drugs With A Protein Content Label Claim Of |
| Classification | Surgeon's Gloves |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2020-12-19 |