The following data is part of a premarket notification filed by Safety Today, Inc. with the FDA for Clean Hand-vcl Glove Dispenser.
Device ID | K897048 |
510k Number | K897048 |
Device Name: | CLEAN HAND-VCL GLOVE DISPENSER |
Classification | Latex Patient Examination Glove |
Applicant | SAFETY TODAY, INC. 7439 OAKMEADOWS DR. Worthington, OH 43085 |
Contact | T Mclaughlin |
Correspondent | T Mclaughlin SAFETY TODAY, INC. 7439 OAKMEADOWS DR. Worthington, OH 43085 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-18 |
Decision Date | 1990-01-25 |