The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Polymer Coated Powder-free Latex Examination Gloves, Contains 50 Micrograms Or Less Of Total Water Extractable Protein P.
| Device ID | K001739 |
| 510k Number | K001739 |
| Device Name: | POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P |
| Classification | Latex Patient Examination Glove |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Contact | Erica Sethi |
| Correspondent | Erica Sethi ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-08 |
| Decision Date | 2000-07-27 |