The following data is part of a premarket notification filed by Kab Gloves Unltd. with the FDA for Masks Surgical Dental.
| Device ID | K900088 |
| 510k Number | K900088 |
| Device Name: | MASKS SURGICAL DENTAL |
| Classification | Mask, Surgical |
| Applicant | KAB GLOVES UNLTD. P.O. BOX 725277 Berkley, MI 48072 |
| Contact | Kirit A Bhatt |
| Correspondent | Kirit A Bhatt KAB GLOVES UNLTD. P.O. BOX 725277 Berkley, MI 48072 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-05 |
| Decision Date | 1990-03-08 |