PRESTIGE AMERITECH

FDA Device Registration & Listing · North Richland Hills, TX, US · Registration 3005022483

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
3005022483
FEI Number
3005022483
Entity Name
PRESTIGE AMERITECH
City/State/Country
North Richland Hills, TX, US
Establishment Address
7201 Iron Horse Blvd., North Richland Hills, TX 76180, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PRESTIGE AMERITECH (Owner Number: 9070341)
Owner / Operator Contact Address
7201 Iron Horse Blvd., --, North Richland Hills, TX 76180, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SafeSecure Pro Gear Face Shields Prestige Ameritech Pediatric/Child's Face Mask ProGear Pro Gear N95 Particulate Filter Respirator and Surgical Mask PRESTIGE AMERITECH FACE MASK Pro Gear Face Mask Dry Shield Fluid Resistant Personal Protection Gown

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EYJ Holder, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2014-10-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-10-24
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-10-24
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2016-06-21
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2017-08-17
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2009-01-12
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2024-10-24
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-10-24
OXZ Pediatric/Child Facemask General, Plastic Surgery Class 2 878.4040 2016-10-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-06-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-06-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-10-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-10-24
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2024-10-24
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2024-10-24
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2022-08-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-10-24
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-10-24
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2012-04-09
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2010-12-06
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2006-11-07
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-10-24
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2020-11-04
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2024-10-24
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2024-10-24
OUK Surgical Mask With Antimicrobial/Antiviral Agent General, Plastic Surgery Class 2 878.4040 2024-10-18
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-10-18
FME Gown, Examination General Hospital Class 1 880.6265 2015-01-13

Official Correspondent

DAN REESE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRESTIGE AMERITECH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3027590916 Anexa Biomedical, Inc. North Richland Hills, TX, US

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 3005022483. Last updated year: 2026. Please use registration number 3005022483 when referencing this establishment in official correspondence.
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