The following data is part of a premarket notification filed by Ansell Intl. with the FDA for Ansell E.p. Extra-protection Examination Gloves.
| Device ID | K895781 |
| 510k Number | K895781 |
| Device Name: | ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES |
| Classification | Patient Examination Glove, Specialty |
| Applicant | ANSELL INTL. LOT 80, AIR KEROH IND. EST. Melaka, MT 75150 |
| Contact | Paul Cacioli |
| Correspondent | Paul Cacioli ANSELL INTL. LOT 80, AIR KEROH IND. EST. Melaka, MT 75150 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-27 |
| Decision Date | 1990-03-09 |