Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026363353

FEI Number

3026363353

Entity Name

AMERICAN ARMOR GLOVES

City/State/Country

West Columbia, SC, US

Establishment Address

4777 12th Street Extension, West Columbia, SC 29172, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

American Armor Gloves (Owner Number: 10087302)

Owner / Operator Contact Address

4777 12th Street Extension, West Columbia, SC 29172, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232654

PMA Number

N/A

All Registered Proprietary Names

Nephron Nitrile Nephron Nitrile, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)

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	2023-07-27
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-07-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-07-27
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-07-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-01-22
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-01-22
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-01-22
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-01-22
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-03-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-03-21
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-03-21
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-03-21

Official Correspondent

Alison Bagwell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

American Armor Gloves

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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3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3042765418	VITAL EDGE INSTRUMENTS LLC	Leesburg, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026363353. Last updated year: 2026. Please use registration number 3026363353 when referencing this establishment in official correspondence.