Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013410562

FEI Number

3013410562

Entity Name

WEAR TEX S. DE R.L. DE C.V.

City/State/Country

Torreon Coahuila, MX

Establishment Address

312 Hilatura, Torreon Coahuila 27272, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Wear Tex S. de R.L. de C.V. (Owner Number: 10052848)

Owner / Operator Contact Address

312 Hilatura, Torreon, MX-COA 27272, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TECHStyles Stockinette X-Span Cotton Stockinette Care-Nett Essential C.A.R.E. Ultra C.A.R.E. Anti-Embolism Stocking (C.A.R.E. brands) Albahealth Guardian compression sleeve LIFESPAN C.A.R.E Span Encompass Group, LLC Guardian Incontinent brief Guardian Hip Panty Guardian Joint Garment Guardian Hip Protector Guardian heel & Elbow Sleeve Guardian Spandex Sleeve Guardian Heel & Elbow Protector Encompass Group, LLC Albahealth Impervious Stockinette Alba Sterile Stockinette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FME	Gown, Examination	General Hospital	Class 1	880.6265	2018-08-30
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2019-04-18
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2023-03-29
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2018-08-30
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2020-08-04
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-03-29
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2018-10-16
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-11-06
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2018-08-30
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2023-03-29
QPC	Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection	General, Plastic Surgery	Class 2	878.4040	2020-04-03
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2020-09-25
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2023-03-29
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2020-08-27
FWW	Table, Operating-Room, Pneumatic	General, Plastic Surgery	Class 1	878.4960	2019-06-06
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-10-12
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2016-10-12
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2020-03-06
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2019-06-07
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2021-11-08
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2023-03-29
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2024-10-17

Official Correspondent

Jessica Lester

US Agent Details

Jessica Lester Business: Encompass Group, LLC Email: Jessica.Lester@EncompassGroup.net Phone: (770) 6262172

Related Public Records

Same Entity

Wear Tex S. de R.L. de C.V.

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
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3005246188	LUCKY IMPEX	Karachi Sindh, PK
3015989060	HINDUSTAN APPAREL INDUSTRIES	Hyderabad Telangana, IN
1000358138	SHAH SAFARI	Seattle, WA, US
3011276959	PATIENTSTYLE MEDICAL LLC	San Leandro, CA, US
3014683120	JMU DENTAL, INC	Fullerton, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013410562. Last updated year: 2026. Please use registration number 3013410562 when referencing this establishment in official correspondence.