The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Powder Free, Hypoallergenic Ambidextrous Patient Examination Gloves.
| Device ID | K945767 |
| 510k Number | K945767 |
| Device Name: | POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ANSELL, INC. 1500 INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
| Contact | Kay Smith |
| Correspondent | Kay Smith ANSELL, INC. 1500 INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-21 |
| Decision Date | 1995-03-02 |