The following data is part of a premarket notification filed by Rantran, Inc. with the FDA for Latex Examination Gloves (powder Free).
Device ID | K926526 |
510k Number | K926526 |
Device Name: | LATEX EXAMINATION GLOVES (POWDER FREE) |
Classification | Latex Patient Examination Glove |
Applicant | RANTRAN, INC. 2624 BEAVER GLEN DR. Ashland, VA 23005 |
Contact | Ed Ransom |
Correspondent | Ed Ransom RANTRAN, INC. 2624 BEAVER GLEN DR. Ashland, VA 23005 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-30 |
Decision Date | 1993-08-24 |