The following data is part of a premarket notification filed by Ansell Edmont Industrial, Inc. with the FDA for Nitra-touch Powder-free Nitrile Medical Examination Glove.
| Device ID | K965095 |
| 510k Number | K965095 |
| Device Name: | NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | ANSELL EDMONT INDUSTRIAL, INC. 1300 WALNUT ST. Coshocton, OH 43812 |
| Contact | Mike W Hagans |
| Correspondent | Mike W Hagans ANSELL EDMONT INDUSTRIAL, INC. 1300 WALNUT ST. Coshocton, OH 43812 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-19 |
| Decision Date | 1997-04-22 |
| Summary: | summary |