Hwa Teh Industrial Sdn. Bhd.
Country not established
- Devices
- 6
What Hwa Teh Industrial Sdn. Bhd. makes
The company manufactures powder-free and pre-powdered latex examination gloves in various formulations, including blue-colored variants. Some products carry specific protein content claims, such as 50 micrograms or less and 140 micrograms or less. These gloves are designed for medical and clinical examination purposes, ensuring compliance with low-protein labeling requirements where applicable.
The portfolio consists of Class I medical devices, regulated under the FDA’s 510(k) clearance pathway. These products are listed in the FDA’s 510(k) database, indicating their compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Hwa (And) Silktex Powder-Free Latex Examination Glove With Protein Labeling Claim (50 Microgram Or Less) Ref K000725
Regimes: 510(k) Registry: 510(k)Powder-Free Latex Examination Gloves-Blue Color Ref K010803
Regimes: 510(k) Registry: 510(k)Hwa Teh Examination Gloves Ref K896251
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hwa Teh Industrial Sdn. Bhd. have in the registry?
The registry currently lists 6 devices for Hwa Teh Industrial Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hwa Teh Industrial Sdn. Bhd.'s devices?
Among its 6 most recently registered devices, Hwa Teh Industrial Sdn. Bhd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Hwa Teh Industrial Sdn. Bhd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Hwa Teh Industrial Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hwa Teh Industrial Sdn. Bhd. in the registry?
The most recently registered devices listed for Hwa Teh Industrial Sdn. Bhd. include HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE, HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS), POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR and HWA TEH EXAMINATION GLOVES.