MedtechSourcebook

Non-Surgical Gown (OEA) contract manufacturers

13 US facilities list FDA product code OEA as a contract manufacturer (8) or contract sterilizer (5).

FDA-registered (openFDA, export of Oct 21, 2026)

FDA device name
Non-Surgical Gown
Product code
OEA (FDA product classification database)
Device class
Class I
Regulation
21 CFR 878.4040
Classification panel
General and plastic surgery

Where they are

California 3 · New York 3 · Texas 3 · North Carolina 2 · Missouri 1 · Wisconsin 1

All 13 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
718 EK INC.3038429287Contract manufacturerGeneral and plastic surgeryBrooklyn, NYNot verifiedOct 21, 2026
BARBARAS DEVELOPMENT, INC.3007207474Contract manufacturerPhysical medicine; Anesthesiology; General hospital +2 moreThousand Oaks, CANot verifiedOct 21, 2026
CURT G. JOA, INC.3002718410Contract manufacturerGeneral and plastic surgerySheboygan Falls, WINot verifiedOct 21, 2026
CUSTOMFAB, INC.2031000Contract manufacturerGeneral and plastic surgery; AnesthesiologyAnaheim, CANot verifiedOct 21, 2026
Haywood Vocational Opportunities Inc.1043549Contract manufacturerGeneral and plastic surgery; General hospital; Gastroenterology and urology +2 moreWaynesville, NCNot verifiedOct 21, 2026
HEARTLAND MANUFACTURING, INC.3023313463Contract manufacturerGeneral and plastic surgeryLong Island City, NYNot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC1643817Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; Cardiovascular +14 moreEl Paso, TXNot verifiedOct 21, 2026
Isomedix Operations Inc3009888344Contract sterilizerGastroenterology and urology; General and plastic surgery; General hospital +13 moreEl Paso, TXNot verifiedOct 21, 2026
MIDWEST STERILIZATION CORP.1928237Contract sterilizerGeneral and plastic surgery; Cardiovascular; General hospital +14 moreJackson, MONot verifiedOct 21, 2026
Sterigenics U.S., LLC1061124Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; General hospital +15 moreCharlotte, NCNot verifiedOct 21, 2026
Sterigenics US LLC3004111573Contract sterilizerGeneral and plastic surgery; Gastroenterology and urology; General hospital +15 moreGrand Prairie, TXNot verifiedOct 21, 2026
TAROMED INC3044467533Contract manufacturerGeneral and plastic surgeryLos Angeles, CANot verifiedOct 21, 2026
TWO ONE TWO NEW YORK, INC.3013269506Contract manufacturerGeneral and plastic surgery; General hospital; RadiologyEdgewood, NYNot verifiedOct 21, 2026

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