Data / Medical devices / Cambodia / Paneffort (cambodia) Garment Co., Ltd.
Paneffort (cambodia) Garment Co., Ltd.: FDA-registered device maker in Pot Sar Ward, Bati District Takeo, Cambodia, 2 510(k) clearances
Paneffort (cambodia) Garment Co., Ltd. is registered with the FDA (registration 3017180923) in Pot Sar Ward, Bati District Takeo, Cambodia. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 30, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017180923
- Address
- National Road No. 2 Kleang Sambatt, Pot Sar Ward, Bati District Takeo, Cambodia, 21309
- Owner or operator
- Paneffort, LLC (10075871)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 14, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cover, Shoe, Operating-Room | FXP | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 30, 2022 | K212717 | Paneffort AAMI Level 3 Isolation Gown | FYC | Substantially Equivalent | Paneffort, LLC | accessdata.fda.gov |
| July 25, 2022 | K221409 | Paneffort 3-ply Surgical and Procedural Masks | FXX | Substantially Equivalent | Paneffort, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Isolation, Surgical
- All makers of Shield, Protective, Personnel
- All makers of Mask, Surgical
- All makers of Cover, Shoe, Operating-Room
- All makers of Drape, Surgical, Exempt
Updated November 30, 2022. 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.