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 |