ARMBRUST INC.

FDA Device Registration & Listing · Elgin, TX, US · Registration 3016866909

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016866909
FEI Number
3016866909
Entity Name
ARMBRUST INC.
City/State/Country
Elgin, TX, US
Establishment Address
1011 Old McDade Rd, Elgin, TX 78621, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Armbrust Inc. (Owner Number: 10073694)
Owner / Operator Contact Address
1011 Old McDade Rd, Building A, Elgin, TX 78621, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222898
PMA Number
N/A

All Registered Proprietary Names

GLOVE-ARMBRUST-3.2MIL-BLUE American Made Surgical Mask Blue Powder-Free Nitrile Exam Gloves

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-12-27
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-03-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-03-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-03-17

Official Correspondent

Oracio Flores

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Armbrust 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
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21
K981039 Sri Johani Sdn. Bhd. POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) 1998-04-21
K101595 Better Care Plastic Technology Cp., Ltd. POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE 2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016866909. Last updated year: 2026. Please use registration number 3016866909 when referencing this establishment in official correspondence.
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