Data / Medical devices / India / Amazing Rubber Products Pvt. Ltd
Amazing Rubber Products Pvt. Ltd: FDA-registered device maker in COCHIN Kerala, India, 4 510(k) clearances
Amazing Rubber Products Pvt. Ltd is registered with the FDA (registration 3024374107) in COCHIN Kerala, India. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 28, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024374107
- Address
- Plot No. 14 C, Csez, Kakkanad, COCHIN Kerala, India, 682037
- Owner or operator
- AMAZING RUBBER PRODUCTS PVT. LTD (10086000)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 9, 2022
- Registered through
- 2026
- Brand names listed
- AMAZING+LATEX EXAMINATION POWDER FREE GLOVES, BLUE NITRILE EXAMINATION GLOVES POWDER FREE, STERILE LATEX SURGICAL GLOVES- POWDER FREE, STERILE NITRILE PATIENT EXAMINATION GLOVES POWDER FREE BLUE COLOR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| May 28, 2022 | K212597 | Amazing+ Latex Examination Powder Free Gloves | LYY | Substantially Equivalent | Amazing Rubber Products Pvt, Ltd. | accessdata.fda.gov |
| May 28, 2022 | K212584 | Blue Nitrile Examination Gloves Powder Free | LZA | Substantially Equivalent | Amazing Rubber Products Pvt, Ltd. | accessdata.fda.gov |
| March 1, 2022 | K212596 | Sterile Latex Surgical Gloves Powder Free | KGO | Substantially Equivalent | Amazing Rubber Products Pvt, Ltd. | accessdata.fda.gov |
| February 17, 2022 | K212586 | Amazing+ | LZA | Substantially Equivalent | Amazing Rubber Products Pvt, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Surgeon'S Gloves
- All makers of Polymer Patient Examination Glove
Updated May 28, 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.