The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Nitrile Powder-free Examination Gloves.
Device ID | K022765 |
510k Number | K022765 |
Device Name: | NITRILE POWDER-FREE EXAMINATION GLOVES |
Classification | Polymer Patient Examination Glove |
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 | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-20 |
Decision Date | 2002-10-11 |
Summary: | summary |