The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Challenge Powder-free, Hypoallergenic, Synthetic Surgical Gloves.
| Device ID | K935917 |
| 510k Number | K935917 |
| Device Name: | CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES |
| Classification | Mask, Oxygen, Non-rebreathing |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Marcia C Leatham |
| Correspondent | Marcia C Leatham BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | KGB |
| CFR Regulation Number | 868.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-10 |
| Decision Date | 1994-02-04 |