The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Triflex Surgeon's Gloves.
Device ID | K832448 |
510k Number | K832448 |
Device Name: | TRIFLEX SURGEON'S GLOVES |
Classification | Surgeon's Gloves |
Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-25 |
Decision Date | 1984-01-27 |