The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Powered Dental Powdered Examination Gloves, With Protein Content Labeling Claim (75 Micrograms Or Less).
| Device ID | K994162 |
| 510k Number | K994162 |
| Device Name: | POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-09 |
| Decision Date | 2000-02-09 |
| Summary: | summary |