The following data is part of a premarket notification filed by Omni Intl., Inc. with the FDA for Omnigrip, Latex Surgical Glove, Powder-free With Protein Labeling Claim.
| Device ID | K984066 |
| 510k Number | K984066 |
| Device Name: | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM |
| Classification | Surgeon's Gloves |
| Applicant | OMNI INTL., INC. 4916 SPRUCE HILL DR. NW Canton, OH 44718 |
| Contact | William E Patton |
| Correspondent | William E Patton OMNI INTL., INC. 4916 SPRUCE HILL DR. NW Canton, OH 44718 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-16 |
| Decision Date | 1999-01-13 |