The following data is part of a premarket notification filed by Ansell Malaysia Sdn Bhd with the FDA for Sterile Extra Protecion Surgeon's Gloves.
| Device ID | K922979 |
| 510k Number | K922979 |
| Device Name: | STERILE EXTRA PROTECION SURGEON'S GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | ANSELL MALAYSIA SDN BHD LOT 80, AIR KEROH INDUSTRIAL ESTATE, Melaka, MY |
| Contact | Paul Cacioli |
| Correspondent | Paul Cacioli ANSELL MALAYSIA SDN BHD LOT 80, AIR KEROH INDUSTRIAL ESTATE, Melaka, MY |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-22 |
| Decision Date | 1995-01-18 |