The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Ultrafree Sterile Latex Powder-free Surgical Gloves.
| Device ID | K964474 |
| 510k Number | K964474 |
| Device Name: | ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1660 IOWA AVE., SUITE 100/200 Riverside, CA 92507 |
| Contact | Ingrid M Hoos |
| Correspondent | Ingrid M Hoos ALLEGIANCE HEALTHCARE CORP. 1660 IOWA AVE., SUITE 100/200 Riverside, CA 92507 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-07 |
| Decision Date | 1997-03-11 |
| Summary: | summary |