The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Glove, Surgeon.
Device ID | K760811 |
510k Number | K760811 |
Device Name: | GLOVE, SURGEON |
Classification | Surgeon's Gloves |
Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-12 |
Decision Date | 1976-11-03 |