The following data is part of a premarket notification filed by Ansell Healthcare Products, Inc. with the FDA for Encore Microptic Powder Free Latex Surgical Gloves, Model 87.
| Device ID | K003769 |
| 510k Number | K003769 |
| Device Name: | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 |
| Classification | Surgeon's Gloves |
| Applicant | ANSELL HEALTHCARE PRODUCTS, INC. 1875 HARSH AVENUE, S.E. Massillon, OH 44646 -7199 |
| Contact | James R Chatterton |
| Correspondent | James R Chatterton ANSELL HEALTHCARE PRODUCTS, INC. 1875 HARSH AVENUE, S.E. Massillon, OH 44646 -7199 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-06 |
| Decision Date | 2000-12-22 |