The following data is part of a premarket notification filed by Trans American Chemical Corp. with the FDA for Tacctile Patient Examination Gloves.
| Device ID | K892958 |
| 510k Number | K892958 |
| Device Name: | TACCTILE PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | TRANS AMERICAN CHEMICAL CORP. 6218 S. LEWIS AVE. SUITE 109 Tulsa, OK 74136 |
| Contact | Mark Reiber |
| Correspondent | Mark Reiber TRANS AMERICAN CHEMICAL CORP. 6218 S. LEWIS AVE. SUITE 109 Tulsa, OK 74136 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-12 |
| Decision Date | 1989-07-14 |