The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Ultrex Powder-free Surgical Gloves/ultrex Powder-free Surgical Gloves With Low Protein Claim.
| Device ID | K964980 |
| 510k Number | K964980 |
| Device Name: | ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM |
| Classification | Surgeon's Gloves |
| Applicant | MAXXIM MEDICAL 104 INDUSTRIAL BLVD. Sugar Land, TX 77478 |
| Contact | Joyce Moody |
| Correspondent | Joyce Moody MAXXIM MEDICAL 104 INDUSTRIAL BLVD. Sugar Land, TX 77478 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-13 |
| Decision Date | 1997-03-06 |