The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Ultra Care Non-sterile Powder Free (green) Natural Rubber Latex Patient Examination Glove.
Device ID | K982505 |
510k Number | K982505 |
Device Name: | ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE |
Classification | Latex Patient Examination Glove |
Applicant | TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 |
Contact | Edward Markovic |
Correspondent | Edward Markovic 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 | 1998-07-20 |
Decision Date | 1999-04-02 |
Summary: | summary |