BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STANDARD TEXTILE CO., INC.

    Reg #: 1527185 · FEI: 1527185 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    72
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    STANDARD TEXTILE CO., INC.
    Registration Number
    1527185
    FEI Number
    1527185
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 Knollcrest Dr
    City
    Cincinnati
    State
    OH
    ZIP
    45237
    Country
    US

    Regulatory Submissions

    510(k) Number
    K950504

    Owner / Operator

    Firm Name
    STANDARD TEXTILE CO., INC.
    Operator Number
    1527185
    Address
    ONE KNOLLCREST DR., --
    City
    Cincinnati
    State
    OH
    Postal Code
    45237
    Country
    US
    Correspondent
    Tim WIRRIG

    Products

    Device Name Product Code
    Drape, Surgical, Exempt PUI
    Gown, Surgical FYA
    Drape, Surgical, Antimicrobial KKX
    Garment, Protective, For Incontinence EYQ
    Gown, Examination FME
    Wrap, Sterilization FRG
    Cover, Mattress (Medical Purposes) FMW
    Fiber, Medical, Absorbent FRL
    Non-Surgical Gown OEA

    Proprietary Names

    Barrier Supreme Drapes Standard Supreme Drapes Perval Surg Gowns STC ID Product Code NH9 Generic Poly Surgical Gowns STC ID Product Code NG7 ComPel MLR Surgical Gowns w/PB70 claims STC ID Product Codes NA1, NA3, NB1, NB3 ComPel Surgical Drapes Comply Adult Briefs STC ID Product Code CB1 Comply Adult Diapers Ultimate, Excel, EStar, Impact, Image First, and Signal Twill Examination Apparel and Xray Gwns within the following lines STC ID Product Code AG8 Promax/Combosafe Surgical Gowns w/PB70 Claims STC ID Product Codes NG9 and NH0 Standard Supreme Sterilization Wrapper ComPel XTR OR Gowns STC ID Product Codes NG3 and NG5 ComPel XTR Zoned OR Gowns SZ1 Barrier Drawsheets CA4 Underpads Integrity CA9 Underpads MD1 Mattress Cover (Medical purposes) STC ID Product Codes CAA, CA0, CA1, CA2, CA3, CA4, CA5, CA6, CA7, CA8, CA9, CA10, MD1, SZ1 CA1 Underpads CAA Underpads Pfeiffer CBO Dermatherapy Underpads Dermatherapy Sheets & Pillowcases Duro CA0 Underpads ATS CA3 Underpads Truval CA6 Underpads Ibex CA5 Underpads Birdseye Pride Spectra CA2 & CA10 Underpads Excel/Comply CA7 Underpads Perval Stanguard Nyloknit CA8 Underpads National Linen Atlas Surpass STC ID Product Codes NE1, NE2, NE3, NE4, NE5, NE7, NF1 - NE1 Toughweave OR Towels NE4 Namewoven OR Towels NE2 Sofsorb OR Towels NE5 Perval OR Towels NF1 OR Towels Imp NE3 Absorbent OR Towels NE7 Estar OR Towels STC ID Product Codes NG1 ComPel Surg OR Gowns Promax Surgical Covers Promax Surgical Drapes ProPel SG3 Surgical Gown Barrier Supreme Sterilization Wrapper Wrappel/S Wrappel/C WrapPel Wrappers STC ID Product Codes ND1, ND2 NG1 ComPel O Surgical Gowns w/PB70 Claims Gown Excel Gown Impact Gown StanGuard Isolation Gowns ComPel Isolation Gowns ComPel Precaution Gowns Generic Barrier Precaution Gowns Non-Surgical Cover Gowns STC ID Product Code AB1, AB2

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device