510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OEAClass I

Non-Surgical Gown

21 CFR 878.4040 / General, Plastic Surgery
FDA source (opens on fda.gov)

OEA is the FDA product code for Non-Surgical Gown, a class I device type, regulated under 21 CFR 878.4040. FDA's definition for this code reads: "A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material". As of , FDA records hold no 510(k) clearances under this code and 17 recalls.

Classification record

Product code
OEA
Device name
Non-Surgical Gown
FDA definition
A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
18

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 550 companies shown, in name order