The following data is part of a premarket notification filed by Stronghold Group Llc with the FDA for Stronghold Group Nitrile Examination Glove, Powder Free.
| Device ID | K213859 |
| 510k Number | K213859 |
| Device Name: | Stronghold Group Nitrile Examination Glove, Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Stronghold Group LLC 98 Foxfire Lane Lewisberry, PA 17339 |
| Contact | David Henderson |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-12-10 |
| Decision Date | 2022-01-13 |