Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680708

FEI Number

1000500301

Entity Name

GALIA TEXTIL S.A. DE C.V.

City/State/Country

XILOXOXTLA, TLAXCALA, MX

Establishment Address

LOTE 3 MANZANA 4, PARQUE INDUSTRIAL, XILOXOXTLA, TLAXCALA 90180, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Galia Textil S.A. de C.V. (Owner Number: 9010816)

Owner / Operator Contact Address

Lote 3 Manzana 4, Parque Ind., Xiloxtla, MX-TLA 90180, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Galia POP Bandage Protector, Antimicrobial Face Mask (Tie On) Galia N95 Professional Respirator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2008-09-02
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-01
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-01

Official Correspondent

No official correspondent registered.

US Agent Details

DAVID LENNARZ Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Galia Textil S.A. 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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2182345	BIRD & CRONIN, LLC	Eagan, MN, US
3017896419	FESUN SHANGHAI CO., LTD.	shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680708. Last updated year: 2026. Please use registration number 9680708 when referencing this establishment in official correspondence.