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 |
D77835055000 | K052666 | 000 |
D77835055050 | K052666 | 000 |
D77835055110 | K052666 | 000 |
D77835086300 | K052666 | 000 |
D77835086320 | K052666 | 000 |
D77835086340 | K052666 | 000 |
D77835086360 | K052666 | 000 |
00817508021037 | K052666 | 000 |
00817508021044 | K052666 | 000 |
00817508021068 | K052666 | 000 |
00817508021075 | K052666 | 000 |
00817508021099 | K052666 | 000 |
00817508020344 | K052666 | 000 |
00817508020382 | K052666 | 000 |
00817508020399 | K052666 | 000 |
D77835054990 | K052666 | 000 |