The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Powder Free Plus Patient Examination Glove.
Device ID | K954855 |
510k Number | K954855 |
Device Name: | POWDER FREE PLUS PATIENT EXAMINATION GLOVE |
Classification | Latex Patient Examination Glove |
Applicant | TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 |
Contact | Imogene Tibbetts |
Correspondent | Imogene Tibbetts TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-23 |
Decision Date | 1995-12-28 |