The following data is part of a premarket notification filed by Ascend Eagle, Inc. with the FDA for Non Sterile Powder-free, Natural Or Aqua Lano-e Nitrile Examination Gloves, With Or Without Citrus/ Peppermint Scent.
| Device ID | K092472 |
| 510k Number | K092472 |
| Device Name: | NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT |
| Classification | Polymer Patient Examination Glove |
| Applicant | ASCEND EAGLE, INC. 198 AVE DE LA DEMERALD Sparks, NV 94589 |
| Contact | Janna Tucker |
| Correspondent | Janna 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 | 2009-08-12 |
| Decision Date | 2010-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817508023745 | K092472 | 000 |
| 00817508020849 | K092472 | 000 |
| 00817508021297 | K092472 | 000 |
| 00817508021327 | K092472 | 000 |
| 00817508021358 | K092472 | 000 |
| 00817508021389 | K092472 | 000 |
| 00817508021419 | K092472 | 000 |
| 00817508022089 | K092472 | 000 |
| 00817508022096 | K092472 | 000 |
| 00817508022201 | K092472 | 000 |
| 00817508020184 | K092472 | 000 |