The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Protekt Gloves.
| Device ID | K910920 |
| 510k Number | K910920 |
| Device Name: | PROTEKT GLOVES |
| Classification | Dress, Surgical |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | FYE |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-05 |
| Decision Date | 1991-05-15 |