Allmed Medical Products Co., Ltd.
Registered establishment in Zhijiang, Hubei, China. 43 device types, 4 clearances.
Allmed Medical Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pad, Eye, Finger Cot and 41 other device types. Its earliest product listing with the FDA dates from 2001.
43device types registered with the FDA
4510(k) clearances
Registration
| Registered name | ALLMED MEDICAL PRODUCTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011862887 |
| FEI number | 3011862887 |
| Establishment type | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Zhijiang |
|---|---|
| Province | Hubei |
| Address | No. 99, Jin Shan Road |
| Postal code | 443200 |
| Country | China |
Group
Allmed Medical Products Co., Ltd. is one of 3 plants registered under ALLMED MEDICAL PRODUCTS CO., LTD..
| Plant | City | Device types |
|---|---|---|
| Allmed Industrial Limited | Shenzhen | 42 |
| Allmed Medical Products Co., Ltd. -Jianli | Jingzhou | 4 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Applicator | 2019 | 186 |
| Bandage, Elastic | Class 1 | Elastic bandages, Elastic Crepe Bandage | 2014 | 280 |
| Bedding, Disposable, Medical | Class 1 | 2018 | 308 | |
| Brush, Cleaning, Tracheal Tube | Class 1 | Brush, Pipe Cleaners | 2012 | 26 |
| Brush, Dermabrasion, Manual | Class 1 | 2022 | 21 | |
| Closure, Wound, Adhesive | Class 1 | 2025 | 22 | |
| Container, Liquid Medication, Graduated | Class 1 | medical cups | 2024 | 68 |
| Container, Specimen, Non-Sterile | Class 1 | Cup with Poly Bag | 2012 | 115 |
| Container, Specimen, Sterile | Class 1 | Sterile Bowl | 2009 | 79 |
| Cotton, Roll | Class 1 | Cotton filled Exodontia sponges | 2013 | 107 |
| Device, Fixation, Tracheal Tube | Class 1 | twill tape | 2024 | 46 |
| Drape, Surgical, Exempt | Class 2 | 2017 | 107 | |
| Dressing, Compression | Class 1 | Elastic Bandage, Bandage Tubular Elasticated, Gauze Bandage, Bandage Tubular, Bandage Elastic Net Tubular | 2014 | 87 |
| Dressing, Wound, Drug | Class U | Impregnated gauze, Antibac bandages, Dressing, Xeroform, Packing Strips, Ido, Iodoform packaging strip, Dressing, Petroleum / Dressing, Oil Emulsion | 2012 | 48 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | 2024 | 118 | |
| Dressing, Wound, Hydrophilic | Class 1 | Hydrophilic Wound Dressing, Super Absorbent Pad | 2014 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Neuro Pads | 2007 | 183 |
| Fentanyl And Other Opioid Protection Glove | Class 1 | 2024 | 29 | |
| Fiber, Medical, Absorbent | Class 1 | 2012 | 172 | |
| Finger Cot | Class 1 | Finger Cot | 2018 | 29 |
| First Aid Kit With Drug | Class N | 2017 | 57 | |
| First Aid Kit Without Drug | Class 1 | First Aid Kit | 2016 | 132 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | plain gauze packing strips, gauze sponge, Non-stick pad, Conforming bandages, Cotton Ball, Absorbent Gauze Roll 100% cotton and 16 more | 2004 | 266 |
| Gauze/Sponge, Internal | Class U | Plain Packing Strips | 2016 | 8 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Gauze Sponge, X-Ray Detectable | 2006 | 67 |
| Kit, Surgical Instrument, Disposable | Class 1 | 2007 | 67 | |
| Marker, Skin | Class 1 | Skin Marker | 2014 | 55 |
| Mask, Surgical | Class 2 | 2021 | 125 | |
| Medical Glove, Specialty | Class 1 | AloeTouch 9” Sterile Powder-Free Stretch Nitrile Exam Gloves,Singles, CURAD Germ Shield Powder-Free Sterile Nitrile Exam Gloves,Pairs, AloeTouch 12” Sterile Powder-Free Stretch Nitrile Exam Gloves,Singles, AloeTouch 12” Sterile Powder-Free Stretch Nitrile Exam Gloves,Pairs | 2024 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | 2024 | 32 | |
| Neurosurgical Paddie | Class 2 | 2014 | 2 | |
| Pad, Eye | Class 1 | EYE PAD, Pad, Eye | 2003 | 100 |
| Pad, Menstrual, Unscented | Class 1 | 2014 | 132 | |
| Pick, Massaging | Class 1 | 2026 | 46 | |
| Polymer Patient Examination Glove | Class 1 | AloeTouch 9” Sterile Powder-Free Stretch Nitrile Exam Gloves,Singles, CURAD Germ Shield Powder-Free Sterile Nitrile Exam Gloves,Pairs, AloeTouch 12” Sterile Powder-Free Stretch Nitrile Exam Gloves,Singles, AloeTouch 12” Sterile Powder-Free Stretch Nitrile Exam Gloves,Pairs | 2024 | 83 |
| Scissors, Medical, Disposable | Class 1 | Scissor | 2018 | 36 |
| Sling, Arm | Class 1 | Triangular Bandage | 2001 | 126 |
| Suture Removal Kit | Class 1 | 2018 | 12 | |
| Tape And Bandage, Adhesive | Class 1 | 2012 | 353 | |
| Tracheobronchial Suction Catheter Kit | Class 1 | Suction catheter kit | 2012 | 9 |
| Tracheostomy And Nasal Suctioning Kit | Class 1 | 2018 | 6 | |
| Tracheostomy Cleaning Tray | Class 2 | Trach Tray, Tracheostomy Clean and Care Tray with 14 FR Suction Catheter, Tracheostomy Clean and Care Tray, Basic Tracheostomy Care kit, Trach Kit | 2012 | 3 |
| Vinyl Patient Examination Glove | Class 1 | SensiCare Sterile Powder-Free Stretch Vinyl Exam Gloves,Singles, patient exam glove (vinyl), SensiCare Sterile Powder-Free Stretch Vinyl Exam Gloves,Pairs | 2009 | 72 |
Clearances
4 clearances name Allmed Medical Products Co., Ltd. as applicant. 8 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K221570 | 2023-09-29 | FRO | Traditional | This company |
| K202128 | 2021-06-03 | FXX | Traditional | This company |
| K202411 | 2021-03-10 | FXX | Traditional | This company |
| K202409 | 2021-03-09 | FXX | Traditional | This company |
| K213040 | 2022-04-27 | LZA | Special | Guangdong Kingfa Medical SCI.&Tech. Co., Ltd. |
| K191753 | 2020-03-17 | LZA | Traditional | Medline Industries, Inc. |
| K142892 | 2015-03-25 | LYZ | Traditional | Shenyi Shandong Plastic Products Co Ltd |
| K121992 | 2012-10-16 | LZA | Traditional | Xinwei (Shandong) Plastic AND Rubber Products Co Ltd. |
| K052720 | 2005-10-20 | FRO | Traditional | Medline Industries, Inc. |
| K012816 | 2002-10-17 | FRO | Traditional | Dynarex Corp. |
| K003091 | 2000-10-24 | LYZ | Traditional | Medline Industries, Inc. |
| K850241 | 1985-03-12 | FRO | Traditional | Alba Health Care |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1997 |
|---|---|
| Employees | 4965 |
| Factory area | 680000 sqm |
| Main products | Wound care dressings, Surgical consumables, Infection control products |
| Certifications | ISO 13485, FDA, CE (TÜV SÜD) |
| Export markets | 70 countries including US, Canada, Germany, Japan |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Allmed Medical (Hubei) Protective Products Co., Ltd. | 8 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.