The following data is part of a premarket notification filed by Biobarrier, Inc. with the FDA for The Double Glove.
| Device ID | K060030 |
| 510k Number | K060030 |
| Device Name: | THE DOUBLE GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | BIOBARRIER, INC. 367 PLEASANT VALLEY RD. P.O. BOX 39 Good Hope, GA 30641 |
| Contact | David W Mullis |
| Correspondent | David W Mullis BIOBARRIER, INC. 367 PLEASANT VALLEY RD. P.O. BOX 39 Good Hope, GA 30641 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-04 |
| Decision Date | 2006-06-27 |
| Summary: | summary |