Data / Medical devices / Sri Lanka / Lalan Rubbers (pvt) Ltd.
Lalan Rubbers (pvt) Ltd.: FDA-registered device maker in Malwana Gampaha, Sri Lanka, 2 510(k) clearances
Lalan Rubbers (pvt) Ltd. is registered with the FDA (registration 3021595900) in Malwana Gampaha, Sri Lanka. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 15, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021595900
- Address
- No. 95/B, Zone A, Export Processing Zone, Biyagama, Malwana Gampaha, Sri Lanka, EPZ 11672
- Owner or operator
- Lalan rubbers (Pvt) Ltd. (10080597)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 23, 2021
- Registered through
- 2026
- Brand names listed
- LE 002, N26088X, N90975X, NE 002
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 15, 2022 | K220697 | Nitrile Patient Examination Gloves, Powder Free | LZA | Substantially Equivalent | Lalan Rubbers (Pvt), Ltd. | accessdata.fda.gov |
| October 6, 2003 | K031386 | LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX | LYY | Substantially Equivalent | Lalan Gloves (Pvt) , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Latex Patient Examination Glove
Updated September 15, 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.