The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Dextren(tm) Powder Free Hypoallergenic Gloves.
| Device ID | K935869 |
| 510k Number | K935869 |
| Device Name: | DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-03 |
| Decision Date | 1994-02-24 |