Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013496867

FEI Number

3013496867

Entity Name

SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD

City/State/Country

Heze Shandong, CN

Establishment Address

South Fanlou Road, Shan County Development Zone, Heze Shandong 274300, CN

Establishment Type(s)

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

Owner / Operator

Shandong Zhushi Pharmaceutical Group Co., Ltd (Owner Number: 10052646)

Owner / Operator Contact Address

South Fanlou Road, Shan County Development Zone, Heze, CN-SD 274300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Theometer Disposable Nitrile Examination Gloves Disposable Medical Face Mask, Protective Suit, Medical Isolation Mask Disposable Oxygen Mask Disposable Sterile Syringe, Disposable Sterile Insulin Syringe, Disposable Sterile Injection Needles Face Mask Disposable Medical Face Mask Acupoint Therapy Patch / Detox Foot Patch / Foot Pad, Magnetic Therapy Patch Disposable Surgical Face Mask Isolation Gown Protective Suit Medical Oxygen Bag BIB/dental bib Disposable Vinyl Examination Gloves Infrared Thermometer Disposable Sputum Suction Bag ECG cable Silicone Scar Gel Silicone Scar Patch Single Patient Breathing Tube Breathing Tube, Endotracheal Tube Holder, Endotracheal Tube Support Clip, Breathing Tube Supports, Stomach Tube (Gastric Calibration Tube), Leving tube, Feeding tube, Enteral feeding bag UNIT, SYRINGE, AIR ANDIOR WATER Thermoplastic Mouth Tray, Mouth Piece/Dental mouthpiece,Teeth whitening tray; TRAY, IMPRESSION, PREFORMED Menstrual cup Disposable Body Surface Drainage Tube Portable Oral Imigator Rechangeable, SINUS IRRIGATOR, Nasal WashBottle Cordless Oral Irigator/Cordless DentalFlosser, Teether, Nozzle Tips for Water Flosser Oral irrigation unit/Dental Oral Irrigator, Water Flosser, DentalFlosser, Dental Water Jet, Medical Isolation Shoe Cover Single use sampler Mouthwash, Denture cleansing tablets, Cleanser, Denture, Denture Cleanser Disposable Medical Gauze / Sponge, Gauze Sponges, Non Woven Sponges, Non Woven Swabs, Abdominal Pads Disposable Medical Face Mask PROBE, PERIODONTIC, Mouth Mirror Fiberglass Casting Tape, Gypsum powder First-aid Bandage Disposable Nasal Oxygen Tube Heat pads Cooling Gel Patch, Heat pads, Cold Compress Gel Far-infrared Physiotherapy Patch/Magnetic heat Patch/Ironing Therapy Patch/Disposable Infusion Hot Compress Patch Heat Patch / Hyperthermia Patch/Gynecological Heat Patch/Steam Eye Mask Medical Ice Pad/Medical Ice Cap/Medical Antipyretic Patch/Medical Antipyretic Gel Sandwiched Moxibustion/Cauterize Hot Patch/Photoconductive Gel/Photon Cold Gel Disposable Sterile Irrigator medical polymer splint Syringe Luer lock tip Cap Drainage Bags Vaginal scrubber Disposable Surgical Face Mask Disposable Medical Laryngeal Mask Absorbent Cotton Balls, Disinfection Cotton Ball, Swab and Piece, prophy angle, cotton roll/Dental cotton roll Retainer Box, Denture box Medical Tweezers Teeth Whitening Pen, Teeth Whitening Toothpaste, teeth whitening machine, Whitening Materials, Teeth Whitening Kit(Regular Strength Serum,Maximum Strength Serum,Desensitizing Serum,Teeth Whitening GEL> , Dione Cold Light Tooth WhiteningInstrument, Enamel Care/Colour Corrector/Hyaluronic Serum Vaginal Stuffing Adsorb Plug

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PXH	Thermometer Kit	General Hospital	Class 2	880.2910	2020-03-11
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-05-05
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-31
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2021-04-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-10-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-10-31
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-11
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-31
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2016-09-01
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-08-09
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-11
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2023-02-21
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2023-02-21
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2021-03-07
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-05-05
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2021-04-15
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2023-02-21
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2018-06-24
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2024-10-14
PRM	Enteral Administration Kit (Adult & Pediatric)	Gastroenterology, Urology	Class 2	876.5980	2024-10-14
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2023-02-21
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2023-02-21
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2019-12-26
OAJ	Catheter, Drainage, Intraoral/Extraoral	General, Plastic Surgery	Class 1	878.4200	2021-12-12
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2023-02-21
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2023-02-21
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2021-04-15
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-01-13
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2023-02-21
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2023-12-03
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-03-31
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2023-02-21
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2018-11-20
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2023-12-03
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2021-04-15
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2016-09-01
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2021-04-15
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2018-11-20
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2023-12-03
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2021-04-15
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2019-12-26
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-08-09
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2021-04-15
EFN	Cotton, Roll	Dental	Class 1	872.6050	2021-04-06
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-02-21
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2021-04-15
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2023-02-21
HEC	Insufflator, Vaginal	Obstetrics/Gynecology	Class 1	884.5920	2021-12-12

Official Correspondent

Kunfu Zhu

US Agent Details

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

Related Public Records

Same Entity

Shandong Zhushi Pharmaceutical 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
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013496867. Last updated year: 2026. Please use registration number 3013496867 when referencing this establishment in official correspondence.