Guangdong Kingfa Medical SCI.&Tech. Co., Ltd.
Manufacturer and brand owner in Qingyuan, Guangdong, China. 5 device types, 9 products catalogued, 14 clearances.
Guangdong Kingfa Medical SCI.&Tech. Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Mask, Surgical, Medical Glove, Specialty and 3 other device types. 9 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
5device types registered with the FDA
9products catalogued under its own name
14510(k) clearances
Registration
| Registered name | GUANGDONG KINGFA MEDICAL SCI.&TECH. CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3045062172 |
| FEI number | 3045062172 |
| DUNS | 543265548 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Qingyuan |
|---|---|
| Province | Guangdong |
| Address | NO. 36 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China |
| Postal code | 511500 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | Class 1 | Powder Free Nitrile Examination Gloves | 2022 | 29 |
| Mask, Surgical | Class 2 | Medical Protective Mask (model: KF-A F02(N)), Medical surgical mask (model: KF-B P05), Medical surgical mask (model: KF-B P05(L3)) colors: blue, pink, purple, white, Medical Surgical Mask : KF-B P06, Medical Surgical Mask : KF-B P06(L3), Biodegradable Medical surgical mask:SPROUT-P11E(L1) | 2026 | 125 |
| Medical Glove, Specialty | Class 1 | Powder Free Nitrile Examination Gloves | 2022 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | Powder Free Nitrile Examination Gloves | 2022 | 32 |
| Polymer Patient Examination Glove | Class 1 | Powder Free Nitrile Examination Gloves, Biodegradable Powder Free Nitrile Examination Gloves : BIO-G05, Biodegradable Powder Free Nitrile Examination Gloves : BIO-G01, Biodegradable Powder Free Nitrile Examination Gloves : BIO-G02 | 2021 | 83 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Kingfa Medical | LZA | 12 |
| Kingfa | FXX | 5 |
| M Track | QDO | 4 |
| Aura | LZA | 4 |
| Kingfa | QDO | 2 |
| Kingfa Medical | FXX | 2 |
| Maadho | LZA | 1 |
| Saniflex | FXX | 1 |
| Kingfamedical | FXX | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233723 | 2024-07-29 | FXX | Traditional | This company |
| K231155 | 2023-11-07 | FXX | Traditional | This company |
| K221983 | 2023-04-27 | LZA | Traditional | This company |
| K230046 | 2023-03-25 | LYZ | Traditional | This company |
| K222612 | 2022-11-25 | LYY | Traditional | This company |
| K222714 | 2022-10-07 | LZA | Special | This company |
| K221887 | 2022-09-24 | LZA | Traditional | This company |
| K213040 | 2022-04-27 | LZA | Special | This company |
| K213450 | 2022-04-05 | FXX | Traditional | This company |
| K211220 | 2021-07-22 | LZA | Traditional | This company |
| K203593 | 2021-03-19 | LZA | Traditional | This company |
| K202107 | 2021-01-15 | FXX | Traditional | This company |
| K201622 | 2020-11-24 | FXX | Traditional | This company |
| K202139 | 2020-11-20 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1993 |
|---|---|
| Main products | Medical gloves (nitrile), Medical face masks, Protective apparels, Particulate respirators, PPE & Medical supplies |
| Certifications | Shanghai Stock Exchange listed (600143.SH), Quality Certifications |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Guangdong Fuqiang Beauty Equipment Co., Limited | 13 |
| Guangdong Southvo Medical Technology Co., Ltd. | 6 |
| Guangdong Xinyi Optical Co., Ltd. | 5 |
| Wayson Group Co., Ltd. | 4 |
| Guangdong Maidi Medical Co., Ltd. | 4 |
| Guangdong Vyimed Co., Ltd. | 4 |
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.