Foshan Nanhai Plus Medical Co Ltd
Foshan Guangdong, CN
FOSHAN NANHAI PLUS MEDICAL CO LTD appears in FDA device records in Foshan Guangdong, 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 Foshan Nanhai Plus Medical Co Ltd between 2015 and 2022. The busiest year on record is 2022, with 5. The most recent is 2022, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 2 |
| 2021 | 1 |
| 2022 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222480 | Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) | FYA | Substantially Equivalent | |
| K213177 | Plus Medical Cover Gown | FYA | Substantially Equivalent | |
| K211036 | Plus Medical Chemotherapy Gown | FYA | Substantially Equivalent | |
| K212698 | Plus Medical Isolation Gown Level 3 | FYC | Substantially Equivalent | |
| K212610 | Surgical Face Mask | FXX | Substantially Equivalent | |
| K210143 | Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) | FYA | Substantially Equivalent | |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | KKX | Substantially Equivalent | |
| K133075 | Plus Surgical Gowns (EO Sterilized), PMGB-XXX | FYA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006723155 | 3006723155 | FOSHAN NANHAI PLUS MEDICAL CO LTD | Shatou Jiujiang Town, Nanhai District, Foshan Guangdong 528208 CN | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KYRBag, Ice
- QOZBarrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy
- FLGCleaner, Ultrasonic, Medical Instrument
- KKXDrape, Surgical, Antimicrobial
- PUIDrape, Surgical, Exempt
- QKRFace Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- FYCGown, Isolation, Surgical
- FYAGown, Surgical
- FXXMask, Surgical
- OEANon-Surgical Gown
- FQLStocking, Medical Support (For General Medical Purposes)
- FRGWrap, Sterilization
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