The following data is part of a premarket notification filed by Phoenix Medical Technology, Inc. with the FDA for Patient Exaination Gloves.
| Device ID | K945045 |
| 510k Number | K945045 |
| Device Name: | PATIENT EXAINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PHOENIX MEDICAL TECHNOLOGY, INC. U.S. HIGHWAY 521 WEST P.O. BOX 346 Andrews, SC 29510 |
| Contact | Grover C Mixon |
| Correspondent | Grover C Mixon PHOENIX MEDICAL TECHNOLOGY, INC. U.S. HIGHWAY 521 WEST P.O. BOX 346 Andrews, SC 29510 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-14 |
| Decision Date | 1995-01-02 |