The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves.
| Device ID | K171737 |
| 510k Number | K171737 |
| Device Name: | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Ansell Healthcare Products LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
| Contact | Robert Mahler |
| Correspondent | Robert Mahler Ansell Healthcare Products LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-12 |
| Decision Date | 2017-12-29 |
| Summary: | summary |