Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010374972

FEI Number

3010374972

Entity Name

RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD

City/State/Country

Rizhao Shandong, CN

Establishment Address

Heshan Industrial area, Rizhao Shandong 276800, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD (Owner Number: 10044543)

Owner / Operator Contact Address

Heshan Industrial area, Donggang District, Rizhao, CN-SD 276800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SURGICAL FACE MASK Bandage, Liquid, Skin Protectant wet tissues Dental apron /shawl,bib,apron Cap, Surgical Caps,hood,Surgical cap,Surgical cap,DOCTOR CAP,Nurse cap,clip cap,protection hood wet wipes Sickness bag with absorbent pad; Dispenser Vomit bag with absorbent pouch Super-absorbent pouch; Vomit Bag; Emesis bag; Emesis bag with absorbent pouch; Hygienic bag with super absorbent pads; Sickness bag; Disposable Sampling Swab Protective Goggles with or without Vent Absorber, Saliva, Paper NIOSH Surgical N95 Particulate Respirator SQ100Gs NIOSH Surgical N95 Particulate Respirator SQ100Sc Surgical Face Mask Level 1/2/3 Blue, white, pink, green, yellow Non-Surgical Isolation Gown gowns,coverall,medical gown,Isolation Gowns,protection grown/coverall,lab coat,patient cloth Cover, Shoe, Operating-Room check pants,Sleeve cover Absorbent sheet; Biohazard Specimen Bag; Sanitary Absorbent Napkin; Super-absorbent pouch Biohazard Specimen Bag with super absorbent pad; Commode Liner; Hygienic bag; Hygienic bag with super absorbent pad; Commode liner with super absorbent pad; Fiber Medical Absorbent; Absorbent Core Paper; Absorbent Pad; Absorbent Paper; Gauze/Sponge,Nonresorbable For External Use Medical Gauzes,Medical Gauzes roll Accessory, Surgical Apparel, check pants,Sleeve cover, Medical Face Shield with or without Glass RIZ100CVb 3Q KN95 3Q KN95 9505 RIZQ100Sb 3Q FFP 2 NR Dressing kit for Medical Use

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-05-28
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2013-06-25
IWO	Apron, Protective	Radiology	Class 1	892.6500	2016-12-12
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2013-06-25
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2017-12-23
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2026-06-17
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2023-01-30
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2023-03-15
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2013-06-25
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-06-16
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-02-07
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2013-06-25
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2013-06-25
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2026-06-17
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2013-06-25
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2013-06-25
QKU	Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)	Unknown	Class N	N/A	2020-04-22
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-12-12

Official Correspondent

Julia Yu

US Agent Details

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

Related Public Records

Same Entity

RIZHAO SANQI MEDICAL & HEALTH ARTICLES 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010374972. Last updated year: 2026. Please use registration number 3010374972 when referencing this establishment in official correspondence.