The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Powder-free Duraprene Sterile Synthetic Surgical Gloves.
| Device ID | K971381 |
| 510k Number | K971381 |
| Device Name: | POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Contact | Maryalice Smith |
| Correspondent | Maryalice Smith ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw 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 | 1997-04-14 |
| Decision Date | 1997-07-09 |
| Summary: | summary |