The following data is part of a premarket notification filed by Maxxim Medical, Inc. with the FDA for Eudermic Pf Powder-free Surgical Gloves.
Device ID | K001343 |
510k Number | K001343 |
Device Name: | EUDERMIC PF POWDER-FREE SURGICAL GLOVES |
Classification | Surgeon's Gloves |
Applicant | MAXXIM MEDICAL, INC. 308 CHURCH ST. Hone Path, SC 29654 |
Contact | Pallie Stoddard |
Correspondent | Pallie Stoddard MAXXIM MEDICAL, INC. 308 CHURCH ST. Hone Path, SC 29654 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-27 |
Decision Date | 2000-06-12 |