The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Synthetic Medical Gloves.
| Device ID | K944184 |
| 510k Number | K944184 |
| Device Name: | SYNTHETIC MEDICAL GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Marcia C Leatham |
| Correspondent | Marcia C Leatham BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-26 |
| Decision Date | 1994-12-09 |