Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013269506

FEI Number

3013269506

Entity Name

TWO ONE TWO NEW YORK, INC.

City/State/Country

Edgewood, NY, US

Establishment Address

60 Heartland Blvd, Edgewood, NY 11717, US

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Two One Two New York, Inc. (Owner Number: 10077084)

Owner / Operator Contact Address

60 Heartland Blvd, Edgewood, NY 11717, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DISPOSABLE SURGICAL GOWN AAMI LEVEL 2 NON-STERILE DISPOSABLE BOUFFANT CAP TRIPLE LAYER SMS SINGLE LAYER SMS BOUFFANT CAP-DISPOSABLE DISPOSABLE BOUFFANT CAP SINGLE LAYER SMS TRIPLE LAYER SMS BOUFFANT CAP-DISPOSABLE DISPOSABLE BOUFFANT HEADCOVER ANSI/AAMI REUSABLE ISOLATION GOWN LEVEL 1 ANSI/AAMI IIJA COMPLIANT DISPOSABLE ISOLATION GOWN LEVEL 2 ANSI/AAMI DISPOSABLE SURGICAL GOWN AAMI LEVEL 2 NON-STERILE DISPOSABLE ISOLATION GOWN LEVEL 3 ANSI/AAMI DISPOSABLE AAMI ISOLATION GOWN LEVEL 3 LEVEL 2 DISPOSABLE ISOLATION GOWN MODEL 27000L DISPOSABLE ISOLATION GOWN ANSI/AAMI LEVEL 2 LEVEL 2 DISPOSABLE ISOLATION GOWN MODEL 27000XL DISPOSABLE ISOLATION GOWN LEVEL 1 ANSI/AAMI DISPOSABLE BARRIER FACE COVERING LEVEL 1 ANSI/AAMI REUSABLE BARRIER FACE COVERING ASTM 3502 DISPOSABLE BARRIER FACE COVERING LEVEL 2 ANSI/AAMI DISPOSABLE BOOTIES-SHOE COVER ANSI/AAMI DISPOSABLE SHOE COVER DISPOSABLE SLEEVE COVERING ANSI/AAMI DISPOSABLE PE COATED SMS SLEEVE PROTECTOR DISPOSABLE APRON ANSI/AAMI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2023-08-17
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-08-21
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-08-11
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-08-17
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-08-21
IWO	Apron, Protective	Radiology	Class 1	892.6500	2020-08-21

Official Correspondent

Christina Fumei

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Two One Two New York, Inc.

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 3013269506. Last updated year: 2026. Please use registration number 3013269506 when referencing this establishment in official correspondence.