The following data is part of a premarket notification filed by Ascend Eagle, Inc. with the FDA for Non-sterile Powder- Free Peach Color, Nitrile Examination Gloves With Lano-e And Peppermint Citrus Scent.
| Device ID | K101351 |
| 510k Number | K101351 |
| Device Name: | NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT |
| Classification | Polymer Patient Examination Glove |
| Applicant | ASCEND EAGLE, INC. 198 AVE DE LA DEMERALD Sparks, NV 94589 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker ASCEND EAGLE, INC. 198 AVE DE LA DEMERALD Sparks, NV 94589 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-14 |
| Decision Date | 2010-10-15 |
| Summary: | summary |