Handsafe Products Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 2
What Handsafe Products Sdn. Bhd. makes
Handsafe Products Sdn. Bhd. manufactures powder-free latex patient examination gloves with a protein labeling claim of 50 micrograms or less, designed for medical and clinical use. The company also produces a line of hand hygiene and protection products under the Handsafe brand.
These products are classified as Class I medical devices and are listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Powder Free Latex Patient Examination Gloves With Protein Labeling Claim (50 Micrograms Or Less) Ref K000913
Regimes: 510(k) Registry: 510(k)Handsafe Ref K960386
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Handsafe Products Sdn. Bhd. have in the registry?
The registry currently lists 2 devices for Handsafe Products Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Handsafe Products Sdn. Bhd.'s devices?
Among its 2 most recently registered devices, Handsafe Products Sdn. Bhd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Handsafe Products Sdn. Bhd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Handsafe Products Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Handsafe Products Sdn. Bhd. in the registry?
The most recently registered devices listed for Handsafe Products Sdn. Bhd. include POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) and HANDSAFE.