Manufacturer registered with FDA
QUALITY LATEX PRODUCTS (PVT) Ltd.
Downers Grove, IL, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1Sri Lanka
Registered in 3 markets
Where regulators' registries name QUALITY LATEX PRODUCTS (PVT) Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | QUALITY LATEX PRODUCTS (PVT) Ltd. | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | QUALITY LATEX PRODUCTS PVT LTD | 2 | 2017–2021 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | QUALITY LATEX PRODUCTS (PVT) Ltd. | 1 | 2014–2014 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What QUALITY LATEX PRODUCTS (PVT) Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Latex dam | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| QUALITY LATEX PRODUCTS (PVT) LTDFDA reg. 3009056984 | hanwella Western, Sri Lanka | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10039153). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.