The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Duraprene Sterile Synthetic Powder-free Surgical Gloves With Tested For Use With Chemotherapy Drugs Labeling Claim.
| Device ID | K013302 |
| 510k Number | K013302 |
| Device Name: | DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM |
| 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 | 2001-10-03 |
| Decision Date | 2001-12-17 |
| Summary: | summary |