The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Micro-touch Nitrile.
| Device ID | K093523 |
| 510k Number | K093523 |
| Device Name: | MICRO-TOUCH NITRILE |
| Classification | Polymer Patient Examination Glove |
| Applicant | ANSELL HEALTHCARE PRODUCTS LLC 1635 INDUSTRIAL RD. Dothan, AL 36303 |
| Contact | Cynthia A Ingram |
| Correspondent | Cynthia A Ingram ANSELL HEALTHCARE PRODUCTS LLC 1635 INDUSTRIAL RD. Dothan, AL 36303 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-13 |
| Decision Date | 2010-03-04 |
| Summary: | summary |