Cleared Traditional

GLOVES, FLOOR

K780181 · Tillotson Rubber Co., Inc. · General Hospital
Feb 1978
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K780181 is an FDA 510(k) clearance for the GLOVES, FLOOR, a Chair, Blood Donor (Class I — General Controls, product code FML), submitted by Tillotson Rubber Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1978, 18 days after receiving the submission on February 3, 1978. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6140.

Submission Details

510(k) Number K780181 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1978
Decision Date February 21, 1978
Days to Decision 18 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FML — Chair, Blood Donor
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6140