Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005885230

FEI Number

3005885230

Entity Name

ENCOMPASS MEDICAL SUPPLIES, INC LIMITED

City/State/Country

Pudong New Area Shanghai, CN

Establishment Address

Block 13 No.300, Shuang Qiao Road, Pudong New Area, Pudong New Area Shanghai 201208, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Encompass Medical Supplies, Inc Limited (Owner Number: 10058038)

Owner / Operator Contact Address

Block 13 No.300, Shuang Qiao Road, Pudong New Area, Pudong New Area, CN-SH 201208, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060147

PMA Number

N/A

All Registered Proprietary Names

MICROFLEX COBALT Zircon Blue Radnor Quantum IDEAL MICROFLEX INTEGRA EC High Five Aura Bosma MICROFLEX COBALT High Five Ideal

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	2018-06-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-06-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-09-11

Official Correspondent

Stephanie Tan

US Agent Details

Jordan Chang Email: Jordan@encompass-medical.com Phone: (909) 8601908

Related Public Records

Same Entity

Encompass Medical Supplies, Inc 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
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

Similar Registrations

Registration Number	Establishment Name	Location
3030671502	GUANGDONG VYIMED CO., LTD.	Qingyuan Guangdong, CN
9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
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 3005885230. Last updated year: 2026. Please use registration number 3005885230 when referencing this establishment in official correspondence.