The following data is part of a premarket notification filed by Phoenix Medical Technology, Inc. with the FDA for Nitrile Patient Examination Gloves, Powder-free.
| Device ID | K000223 |
| 510k Number | K000223 |
| Device Name: | NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE |
| Classification | Polymer Patient Examination Glove |
| Applicant | PHOENIX MEDICAL TECHNOLOGY, INC. HWY. 521 WEST, P.O. BOX 346 Andrews, SC 29510 |
| Contact | Grover C Mixon |
| Correspondent | Grover C Mixon PHOENIX MEDICAL TECHNOLOGY, INC. HWY. 521 WEST, P.O. BOX 346 Andrews, SC 29510 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-24 |
| Decision Date | 2000-04-14 |