Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1527185

FEI Number

1527185

Entity Name

STANDARD TEXTILE CO., INC.

City/State/Country

Cincinnati, OH, US

Establishment Address

1 Knollcrest Dr, Cincinnati, OH 45237, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

STANDARD TEXTILE CO., INC. (Owner Number: 1527185)

Owner / Operator Contact Address

ONE KNOLLCREST DR., --, Cincinnati, OH 45237, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K923408

PMA Number

N/A

All Registered 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 STC ID Product Codes NA1, NA3, NB1, NB3 Promax Surgical Drapes ProPel SG3 Surgical Gown Barrier Supreme Sterilization Wrapper Wrappel/S Wrappel/C WrapPel Wrappers STC ID Product Codes ND1, ND2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2018-04-24
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-03-22
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-03-22
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2009-11-05
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	1996-08-20
FME	Gown, Examination	General Hospital	Class 1	880.6265	1992-07-07
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-03-22
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-01-05
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-03-22
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2007-05-29
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2006-08-28
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2009-11-05
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2011-03-22
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-11-13
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-01-05
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2009-11-05

Official Correspondent

Tim WIRRIG

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STANDARD TEXTILE CO., INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1527185. Last updated year: 2026. Please use registration number 1527185 when referencing this establishment in official correspondence.