The following data is part of a premarket notification filed by Ansell Healthcare Products, Llc with the FDA for Encore Acclaim Sterile Powder-free Latex Surgical Gloves, Tested For Use With Chemothera.
Device ID | K103714 |
510k Number | K103714 |
Device Name: | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA |
Classification | Surgeon's Gloves |
Applicant | ANSELL HEALTHCARE PRODUCTS, LLC 555 ZANG STREET, SUITE 100 Lakewood, CO 80228 |
Contact | Mary L Armstrong |
Correspondent | Mary L Armstrong ANSELL HEALTHCARE PRODUCTS, LLC 555 ZANG STREET, SUITE 100 Lakewood, CO 80228 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-21 |
Decision Date | 2011-07-07 |
Summary: | summary |