Data / Medical devices / China / Shandong Zhushi Pharmaceutical Group Co., Ltd
Shandong Zhushi Pharmaceutical Group Co., Ltd: FDA-registered device maker in Heze Shandong, China, 6 510(k) clearances
Shandong Zhushi Pharmaceutical Group Co., Ltd is registered with the FDA (registration 3013496867) in Heze Shandong, China. It lists 65 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 17, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013496867
- Address
- South Fanlou Road Shan County Development Zone, Heze Shandong, China, 274300
- Owner or operator
- Shandong Zhushi Pharmaceutical Group Co., Ltd (10052646)
- Roles
- Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer
- First device listed
- September 1, 2016
- Registered through
- 2026
- Brand names listed
- 3-Layer Medical Face Masks (XMM3L3C) / Disposable Surgical Face Mask (ZS-B),, 3-Layer Medical Face Masks with ties (XMM3HT)/Disposable Surgical Face Mask (ZS-S), Absorbent Cotton Balls, Disinfection Cotton Ball, Swab and Piece, prophy angle, cotton roll/Dental cotton roll, Acupoint Therapy Patch / Detox Foot Patch / Foot Pad, Magnetic Therapy Patch, BIB/dental bib, Blood Collection Needle, Blunt tip dispensing needle, scanbody, analog, Breathing Tube, Endotracheal Tube Holder, Endotracheal Tube Support Clip, Breathing Tube Supports, and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Absorber, Saliva, Paper | KHR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Accessories, Retractor, Dental | EIF | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Bag, Reservoir | BTC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Manufacturer | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Drainage, Intraoral/Extraoral | OAJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter, Ventricular, General & Plastic Surgery | GBS | 1 | Manufacturer | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cup, Menstrual | HHE | 2 | Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Douche Apparatus, Vaginal, Therapeutic | HED | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Manufacturer | accessdata.fda.gov |
| Enteral Administration Kit (Adult & Pediatric) | PRM | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Eraser, Dental Stain | MAU | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Manufacturer | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Manufacturer | accessdata.fda.gov |
| Insufflator, Vaginal | HEC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Probe, Periodontic | EIX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Retainer, Surgical | GCZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Manufacturer | accessdata.fda.gov |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 | Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Manufacturer | accessdata.fda.gov |
| Support, Breathing Tube | JAY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Thermometer Kit | PXH | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| August 17, 2022 | K212033 | Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle | FMF | Substantially Equivalent | Shandong Zhushi Pharmaceutical Group Co., Ltd. | accessdata.fda.gov |
| September 22, 2021 | K210772 | 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) | FXX | Substantially Equivalent | Vr Vertical, LLC Dba Xrgo | accessdata.fda.gov |
| August 12, 2021 | K210510 | Disposable Surgical Gown | FYA | Substantially Equivalent | Shandong Zhushi Pharmaceutical Group Co., Ltd. | accessdata.fda.gov |
| April 29, 2021 | K203454 | Infrared Thermometer | FLL | Substantially Equivalent | Shandong Zhushi Pharmaceutical Group Co., Ltd. | accessdata.fda.gov |
| April 28, 2021 | K203436 | Disposable Nitrile Examination Gloves | LZA | Substantially Equivalent | Shandong Zhushi Pharmaceutical Group Co., Ltd. | accessdata.fda.gov |
| February 26, 2021 | K203439 | Disposable Vinyl Examination Gloves | LYZ | Substantially Equivalent | Shandong Zhushi Pharmaceutical Group Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 17, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.