The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Ultra Care 2 Latex Examination Gloves Made From Allotex (enzyme Treated) Natural Rubber Latex With A Protein Content Lab.
Device ID | K002718 |
510k Number | K002718 |
Device Name: | ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB |
Classification | Latex Patient Examination Glove |
Applicant | TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 -5030 |
Contact | F.w. Perrella |
Correspondent | F.w. Perrella TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford, NH 03110 -5030 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-31 |
Decision Date | 2001-05-01 |