Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000521459

FEI Number

1000521459

Entity Name

SIGMATEX, INC. D/B/A/ SIGMATEX-LANIER TEXTILES

City/State/Country

New York, NY, US

Establishment Address

800 Third Avenue, Ste 2303, New York, NY 10022, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Sigmatex, Inc. d/b/a/ Sigmatex-Lanier Textiles (Owner Number: 10075645)

Owner / Operator Contact Address

800 Third Avenue, Suite 2303, New York, NY 10022, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-Surgical Isolation Gowns

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sigmatex, Inc. d/b/a/ Sigmatex-Lanier Textiles

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000521459. Last updated year: 2026. Please use registration number 1000521459 when referencing this establishment in official correspondence.