The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Coated Sterile Latex Powder-free Surgical Gloves With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K992171 |
| 510k Number | K992171 |
| Device Name: | COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-28 |
| Decision Date | 1999-09-14 |
| Summary: | summary |