Makrite Industries, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Disposable Medical Face Mask, Disposable Medical Face Mask (M643BE), Disposable Surgical Face Mask (M663BE, M663BT)
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Makrite Industries, Inc. General Hospital ✕
4 devices
Cleared
Jan 05, 2026
Disposable Medical Face Mask
General Hospital
136d
Cleared
Apr 18, 2024
Disposable Medical Face Mask (M643BE)
General Hospital
78d
Cleared
Jun 14, 2022
Disposable Surgical Face Mask (M663BE, M663BT)
General Hospital
109d
Cleared
Jul 23, 2002
MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95
General Hospital
161d