The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Ultrafree Max Sterile Latex Poweder-free Surgical Gloves With Protein Labeling Claim, 50 Per Gram Or Less Of Total Water.
| Device ID | K010862 |
| 510k Number | K010862 |
| Device Name: | ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER |
| Classification | Surgeon's Gloves |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
| Contact | Erica Sethi |
| Correspondent | Erica Sethi ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-22 |
| Decision Date | 2001-06-07 |