The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Ansell No Powder Ambi Patient Examination Gloves.
| Device ID | K913766 |
| 510k Number | K913766 |
| Device Name: | ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ANSELL, INC. P.O. BOX 18 LAT KRABANG, BANGKOK 10520 Thailand, TH |
| Contact | John W Moushall |
| Correspondent | John W Moushall ANSELL, INC. P.O. BOX 18 LAT KRABANG, BANGKOK 10520 Thailand, TH |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-22 |
| Decision Date | 1993-03-11 |