STANDARD TEXTILE CO., INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
15271851527185STANDARD TEXTILE CO., INC.1N2026-01-011 Knollcrest Dr Cincinnati OH US 45237

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
29371967602222K980183PROMAX SURGICAL DRAPES AND COVERSKKX1998-02-26
29371824002334K950504PERVAL SURGICAL GOWN (MARKETING NAME)FYA1995-04-25
29371897256887K923811COMPEL SURGICAL DRAPESKKX1993-02-23
29371853327735K923408WRAPPEL TFRG1993-04-08
29371105120865K922753COMPEL XTRFYA1993-03-09
29371249779406K921889COMPEL O AND RFYA1993-02-18
29371212894225K241214ProPel SG3™ Surgical GownFYA2024-09-10
29371427135033K172207Standard Supreme Sterilization WrapperFRG2017-08-25
29372066583891K162162Barrier Supreme Sterilization WrapperFRG2016-11-04
29371013738419K041541COMPEL MLR SURGICAL GOWNSFYA2005-03-16
29371461668527K041540COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNSFYA2005-05-05
29371240036947K041539COMPEL SURGICAL GOWNSFYA2005-04-28
29371382461712
29371429034384
29371495855430
29371996502996
29372053946361
29372068193513

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
FYA72024-09-10
FRG32017-08-25
KKX21998-02-26

PMN

WRAPPEL T

1993-04-08

STANDARD TEXTILE CO., INC.

COMPEL E

1992-04-02

STANDARD TEXTILE CO., INC.

GUDID

OR Gown

2026-03-11

STANDARD TEXTILE CO., INC.

200 records. Showing 1-40. Next