The following data is part of a premarket notification filed by Ansell Intl. with the FDA for Nutex Gloves.
| Device ID | K920745 |
| 510k Number | K920745 |
| Device Name: | NUTEX GLOVES |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-07 |
| Decision Date | 1993-01-21 |