Hartalega Sdb. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 4
What Hartalega Sdb. Bhd. makes
Hartalega Sdb. Bhd. manufactures latex polymer-coated powder-free surgical gloves with a protein labeling claim of 50 micrograms or less per gram, including natural and green variants, as well as powdered examination gloves with a protein claim of 200 micrograms or less per gram. The company also produces nitrile powder-free examination gloves tested for use with chemotherapy drugs, available in white, dark violet blue, and dark blue.
These devices are classified under Class I in the FDA regulatory framework and are listed under 510(k) clearance. The manufacturer is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Latex Powdered Examination Gloves With Protein Labeling Claim Of 200 Microgram Or Less Per Gram Of Glove Ref K142270
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hartalega Sdb. Bhd. have in the registry?
The registry currently lists 4 devices for Hartalega Sdb. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hartalega Sdb. Bhd.'s devices?
Among its 4 most recently registered devices, Hartalega Sdb. Bhd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Hartalega Sdb. Bhd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Hartalega Sdb. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hartalega Sdb. Bhd. in the registry?
The most recently registered devices listed for Hartalega Sdb. Bhd. include Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green), LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE and Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU).