The following data is part of a premarket notification filed by Allegiance Healthcare Coporation with the FDA for Flexam Nitrile T Ambi Examination Gloves With Chemo Claim.
| Device ID | K000813 |
| 510k Number | K000813 |
| Device Name: | FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM |
| Classification | Polymer Patient Examination Glove |
| Applicant | ALLEGIANCE HEALTHCARE COPORATION 1500 WAUKERGAN RD. Mcgaw Park, IL 60085 |
| Contact | Erica Sethi |
| Correspondent | Erica Sethi ALLEGIANCE HEALTHCARE COPORATION 1500 WAUKERGAN RD. 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 | 2000-03-13 |
| Decision Date | 2000-06-08 |