Data / Medical devices / China / Arrow Medsource Group Limited
Arrow Medsource Group Limited: FDA-registered device maker in Hongkong, China, 6 510(k) clearances
Arrow Medsource Group Limited is registered with the FDA (registration 3016685880) in Hongkong, China. It lists 17 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 17, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016685880
- Address
- Flat 10, 3/F Wah Yiu Indus 30-32 Au Pui Wan Street Sha, Tin, NT, Hongkong, China, 999077
- Owner or operator
- Arrow Medsource Group Limited (10064458)
- Roles
- Contract manufacturer, Exporter to the US, Specification developer
- First device listed
- March 25, 2020
- Registered through
- 2026
- Brand names listed
- AMG, Bouffant Cap, Catheter And Tip, Suction, Disposable Shoe Covers, General Face Mask, Gown Examination, Isolation Gown, Chemo Gown; Coverall with tape; Coverall w/o tape; Disposable Coverall; Disposable Isolation Gown, Ophthalmic Eye Shield and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Contract manufacturer, Exporter to the US, Specification developer | 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 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Contract manufacturer, Exporter to the US, Specification developer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Contract manufacturer, Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 17, 2020 | K193526 | Syringe with safety needle, Safety needle | FMF | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| February 6, 2017 | K162923 | NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| July 17, 2013 | K123787 | GREENCROSS SURGICAL MASK | FXX | Substantially Equivalent | Jingzhou Haixin Green Cross Medical Products Co.,L | accessdata.fda.gov |
| September 4, 2009 | K091652 | NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| July 23, 2002 | K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | MSH | Substantially Equivalent | Makrite Industries, Inc. | accessdata.fda.gov |
| February 9, 2001 | K003985 | POWDERFREE NITRILE PATIENT EXMINATION GLOVE | LZA | Substantially Equivalent | Guthrie Medicare Products (Melaka) Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Catheter And Tip, Suction
- All makers of Tubing, Pressure And Accessories
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Updated July 17, 2020. 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.