Shandong Zhushi Pharmaceutical Group Co., Ltd
Heze Shandong, CN
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD appears in FDA device records in Heze Shandong, CN. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Shandong Zhushi Pharmaceutical Group Co., Ltd between 2021 and 2024. The busiest year on record is 2021, with 6. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 6 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232475 | Disposable infusion set with needle | FPA | Substantially Equivalent | |
| K212033 | Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle | FMF | Substantially Equivalent | |
| K210510 | Disposable Surgical Gown | FYA | Substantially Equivalent | |
| K210643 | Disposable Surgical Face Mask | FXX | Substantially Equivalent | |
| K210409 | Disposable Surgical Face Mask | FXX | Substantially Equivalent | |
| K203454 | Infrared Thermometer | FLL | Substantially Equivalent | |
| K203436 | Disposable Nitrile Examination Gloves | LZA | Substantially Equivalent | |
| K203439 | Disposable Vinyl Examination Gloves | LYZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013496867 | 3013496867 | SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD | South Fanlou Road, Heze Shandong 274300 CN | 2026 | and 55 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- NDPAccessories, Implant, Dental, Endosseous
- EIFAccessories, Retractor, Dental
- LYUAccessory, Surgical Apparel
- CAEAirway, Oropharyngeal, Anesthesiology
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- KXFApplicator, Absorbent Tipped, Non-Sterile
- KXGApplicator, Absorbent Tipped, Sterile
- BTCBag, Reservoir
- ITGBandage, Cast
- IKDCable, Electrode
- CATCannula, Nasal, Oxygen
- FYFCap, Surgical
- GBSCatheter, Ventricular, General & Plastic Surgery
- EFTCleanser, Denture, Over The Counter
- BTICompressor, Air, Portable
- FLLContinuous Measurement Thermometer
- EFNCotton, Roll
- HHECup, Menstrual
- EIEDam, Rubber
- KYXDispenser, Liquid Medication
- HEDDouche Apparatus, Vaginal, Therapeutic
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- MDAElastomer, Silicone, For Scar Management
- MAUEraser, Dental Stain
- EMGForceps, Tooth Extractor, Surgical
- NABGauze / Sponge,Nonresorbable For External Use
- FYAGown, Surgical
- HRQHemostat
- HECInsufflator, Vaginal
- KARIrrigator, Sinus
- BYGMask, Oxygen
- KHAMask, Scavenging
- FXXMask, Surgical
- LYGMassager, Therapeutic, Manual
- JRCMicro Pipette
- EAXMirror, Mouth
- DYNMouthpiece, Saliva Ejector
- DZMNeedle, Dental
- FMINeedle, Hypodermic, Single Lumen
- IMDPack, Hot Or Cold, Disposable
- IMEPack, Hot Or Cold, Reusable
- HMPPad, Eye
- LZAPolymer Patient Examination Glove
- EIXProbe, Periodontic
- GCZRetainer, Surgical
- FPASet, Administration, Intravascular
- BWPShoe And Shoe Cover, Conductive
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- FXOSuit, Surgical
- JAYSupport, Breathing Tube
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
- KGXTape And Bandage, Adhesive
- EHYTray, Impression, Preformed
- EFSUnit, Oral Irrigation
- ECBUnit, Syringe, Air And/Or Water
- LYZVinyl Patient Examination Glove
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain