The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Gloves, Aparticulate Surgical.
Device ID | K760248 |
510k Number | K760248 |
Device Name: | GLOVES, APARTICULATE SURGICAL |
Classification | Surgeon's Gloves |
Applicant | DEKNATEL, INC. 600 AIRPORT RD. Fall River, MA 02720 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-19 |
Decision Date | 1976-08-09 |