The following data is part of a premarket notification filed by Thai Fuji Latex Co., Ltd. with the FDA for Surgeon's Gloves.
| Device ID | K893522 |
| 510k Number | K893522 |
| Device Name: | SURGEON'S GLOVES |
| Classification | Dislodger, Stone, Flexible |
| Applicant | THAI FUJI LATEX CO., LTD. 650 CALIFORNIA ST. SUITE 2550 San Francisco, CA 94108 |
| Contact | Roger J Fleischmann |
| Correspondent | Roger J Fleischmann THAI FUJI LATEX CO., LTD. 650 CALIFORNIA ST. SUITE 2550 San Francisco, CA 94108 |
| Product Code | FGO |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-08 |
| Decision Date | 1990-01-22 |