MACClass I

Decontamination Kit

General, Plastic Surgery · 21 CFR 878.4014

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

MDR events15All time

Recalls1All time

Registered firms15Currently listed

510(k) clearances2All time

Recent MDR events

15 adverse event reports on file

Event type breakdown

Malfunction13

Injury2

Most-reported manufacturers

Emergent Biosolutions10 Macoproductions S.a.s.1 Medical Action Industries Inc.1 Sage Products Llc1 Stryker Orthopaedics Limerick1 Tyco Healthcare Group Lp1

Recalls

1 recall events for this product code

Emergent Protective Products USA Inc
TerminatedJan 10, 2023
RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.
Complaints of leaking packets were received.
Z-0773-2023 · View FDA record ↗

Registered firms

15 firms currently registered for this product code

510(k) clearances

2 clearances for this product code