The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Pure Advantage Nitrile Hypoallergenic Surgical Glove.
Device ID | K972009 |
510k Number | K972009 |
Device Name: | PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE |
Classification | Surgeon's Gloves |
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 | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-30 |
Decision Date | 1997-09-12 |
Summary: | summary |