Data / Medical devices / Peru / R & G Seguridad E Higiene Industrial S.A.C.
R & G Seguridad E Higiene Industrial S.A.C.: FDA-registered device maker in VENTANILLA Lima(Province), Peru, 1 510(k) clearance
R & G Seguridad E Higiene Industrial S.A.C. is registered with the FDA (registration 3016714803) in VENTANILLA Lima(Province), Peru. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016714803
- Address
- Mza. V Lote 11 Urb. Los Carrizales Prov. Const. Del Callao, VENTANILLA Lima(Province), Peru, 07046
- Owner or operator
- R & G SEGURIDAD E HIGIENE INDUSTRIAL S.A.C. (10082241)
- Roles
- Manufacturer
- First device listed
- June 27, 2022
- Registered through
- 2026
- Brand names listed
- Examination Gown, Non-surgical gown, Shoe cover, Surgical Drape, Surgical Helmet, Surgical Mask, Surgical Suit, Surgical cap and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cap, Surgical | FYF | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Ent | ERY | 2 | Manufacturer | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Manufacturer | accessdata.fda.gov |
| Helmet, Surgical | FXZ | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 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 |
|---|---|---|---|---|---|---|
| April 2, 2024 | K232112 | R&G Surgical Mask | FXX | Substantially Equivalent | R&G Seguridad E Higiene Industrial S.A.C. | accessdata.fda.gov |
Compare with other makers
- All makers of Suit, Surgical
- All makers of Dress, Surgical
- All makers of Gown, Examination
- All makers of Non-Surgical Gown
- All makers of Drape, Surgical, Ent
- All makers of Helmet, Surgical
Updated April 2, 2024. 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.