The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Nitrile Powder-free Examination Gloves.
| Device ID | K022765 |
| 510k Number | K022765 |
| Device Name: | NITRILE POWDER-FREE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-20 |
| Decision Date | 2002-10-11 |
| Summary: | summary |