The following data is part of a premarket notification filed by Ascend Eagle, Inc. with the FDA for Non-sterile Powder Free Natural/green Lano-e Latex Exam Gloves, With Or Wihout Citrus/peppermint Scent Plus A Protein.
| Device ID | K052666 |
| 510k Number | K052666 |
| Device Name: | NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN |
| Classification | Latex Patient Examination Glove |
| Applicant | ASCEND EAGLE, INC. 140-B DODD CT. American Canyon, CA 94503 |
| Contact | Jarilyn Lim |
| Correspondent | Jarilyn Lim ASCEND EAGLE, INC. 140-B DODD CT. American Canyon, CA 94503 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-27 |
| Decision Date | 2006-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817508020412 | K052666 | 000 |
| 00817508020399 | K052666 | 000 |
| 00817508020382 | K052666 | 000 |
| 00817508020344 | K052666 | 000 |
| 00817508021099 | K052666 | 000 |
| 00817508021075 | K052666 | 000 |
| 00817508021068 | K052666 | 000 |
| 00817508021044 | K052666 | 000 |
| 00817508021037 | K052666 | 000 |