The following data is part of a premarket notification filed by Dynamic Marketing Ent. with the FDA for Physician Barrier Glove, Surgical.
| Device ID | K901221 |
| 510k Number | K901221 |
| Device Name: | PHYSICIAN BARRIER GLOVE, SURGICAL |
| Classification | Accessory, Surgical Apparel |
| Applicant | DYNAMIC MARKETING ENT. 108 COMMERCE ST. SUITE 105 Lake Mary, FL 32746 |
| Contact | Victor Ragucci |
| Correspondent | Victor Ragucci DYNAMIC MARKETING ENT. 108 COMMERCE ST. SUITE 105 Lake Mary, FL 32746 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-14 |
| Decision Date | 1990-07-10 |