Hubei Haixin Protective Products Group Co.,Ltd

FDA Device Registration & Listing · Songzi City Hubei, CN · Registration 3004158259

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004158259
FEI Number
3004158259
Entity Name
Hubei Haixin Protective Products Group Co.,Ltd
City/State/Country
Songzi City Hubei, CN
Establishment Address
Jinsong Avenue 8-8,Chengdong Industrial Zone, Songzi City Hubei 434205, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Hubei Haixin Protective Products Group Co.,Ltd (Owner Number: 9058446)
Owner / Operator Contact Address
Jinsong Avenue 8-8,Chengdong Industrial Zone, Songzi, CN-HB 434205, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222266
PMA Number
N/A

All Registered Proprietary Names

Cover Gown; Coverall; Impervious Gown; Isolation Gown; Lab Coat; Lab Jacket; Thumbloop Gown Non-surgical isolation gown Earloop Procedure Mask Suit Surgical Bouffant Cap Face Shield CPE MATTRESS COVER,PP MATTRESS COVER AAMI 3 Fld Resist Surgical Isolation Gown Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)

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 2008-04-08
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2013-07-25
FXO Suit, Surgical General, Plastic Surgery Class 1 878.4040 2011-10-18
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2006-03-13
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2008-04-08
FMW Cover, Mattress (Medical Purposes) General Hospital Class 1 880.6190 2008-04-08
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2020-01-19
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-12-21

Official Correspondent

Eric Yang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Hubei Haixin Protective Products Group 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
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004158259. Last updated year: 2026. Please use registration number 3004158259 when referencing this establishment in official correspondence.
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