Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017467279

FEI Number

3017467279

Entity Name

ENVIRONSTAR GROUP COMPANY LIMITED

City/State/Country

Hung Yen Province, VN

Establishment Address

Lot DH 2 & V-1 Cau Nghin Industrial Zone, Phu Duc commune, Hung Yen Province 410000, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ENVIRONSTAR GROUP COMPANY LIMITED (Owner Number: 10076505)

Owner / Operator Contact Address

Lot DH 2 and Lot V-1, Cau Nghin Industrial Zone, Phu Duc commune, Hung Yen Province, VN-NOTA 410000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medline Brand Ultrasonic Isolation Gown Medline Brand Clip Cap Medline brand isolation gown

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	2022-11-08
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2021-08-17
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2023-03-01
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-07-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-07-02
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-20
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-07-02
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-07-02

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

ENVIRONSTAR GROUP COMPANY LIMITED

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
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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3021286079	PURCEL LABS LLC	Los Angeles, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017467279. Last updated year: 2026. Please use registration number 3017467279 when referencing this establishment in official correspondence.