The following data is part of a premarket notification filed by Phoenix Medical Technology, Inc. with the FDA for Modified Low Powder Single Use Latex Exam Gloves.
| Device ID | K900454 |
| 510k Number | K900454 |
| Device Name: | MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PHOENIX MEDICAL TECHNOLOGY, INC. HWY. 521 WEST, P.O. BOX 346 Andrews, SC 29510 |
| Contact | J. F Sauve' |
| Correspondent | J. F Sauve' PHOENIX MEDICAL TECHNOLOGY, INC. HWY. 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 | 1990-01-30 |
| Decision Date | 1990-02-13 |