The following data is part of a premarket notification filed by Infab Corp. with the FDA for Radiation Protection Gloves.
| Device ID | K900972 |
| 510k Number | K900972 |
| Device Name: | RADIATION PROTECTION GLOVES |
| Classification | Radiographic Protective Glove |
| Applicant | INFAB CORP. 3651 VIA PESCADOR Camarillo, CA 93012 |
| Contact | Don Cusick |
| Correspondent | Don Cusick INFAB CORP. 3651 VIA PESCADOR Camarillo, CA 93012 |
| Product Code | IWP |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-02 |
| Decision Date | 1990-05-01 |