Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014345238

FEI Number

3014345238

Entity Name

OPUS GLOVES CO.,LTD.

City/State/Country

shanghai, CN

Establishment Address

288 juchen rd, jiading, shanghai 201821, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

opus gloves co.,ltd. (Owner Number: 10057196)

Owner / Operator Contact Address

288 juchen rd, jiading, shanghai, CN-HE 201821, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Polymer patient examination glove patient examination glove Vinyl Polymer patient examination glove Polymer patient examination glove Vinyl patient examination glove Vinyl patient examination glove Vinyl patient examination glove

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-12-18
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-12-18
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-12-18
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-12-18
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2018-07-02
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-02-20
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-01-13
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-01-13
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2021-06-17
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2024-12-19
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2018-07-02

Official Correspondent

Alicia li

US Agent Details

shi Da Email: info@medicaldevice.org Phone: (949) 7678188

Related Public Records

Same Entity

opus gloves co.,ltd.

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
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US
3036774599	PT NEWPOINT TECHNOLOGY	Simalungun Sumatera Utara, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014345238. Last updated year: 2026. Please use registration number 3014345238 when referencing this establishment in official correspondence.