The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Maxxus Orthopaedic Surgical Gloves.
| Device ID | K953641 |
| 510k Number | K953641 |
| Device Name: | MAXXUS ORTHOPAEDIC SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
| Contact | Margaret L Marsh |
| Correspondent | Margaret L Marsh JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-04 |
| Decision Date | 1995-09-15 |