Careplus (M) Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 10
What Careplus (M) Sdn Bhd makes
Careplus (M) Sdn Bhd manufactures powder-free latex and nitrile examination and surgical gloves. Their latex gloves include powder-free varieties with protein content labeling claims (≤50 µg/g or ≤50 µg/dm²) and some are tested for use with chemotherapy drugs. Nitrile examination gloves are also offered in colored variants, including blue, white, black, and dual-color options, with some tested for chemical resistance.
The company’s products fall under Class I medical devices and are listed via FDA 510(k) clearance. Their portfolio is regulated under US jurisdiction, with no additional international registries referenced.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Latex Examination Glove Powder Free Ref K152593
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- 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 Careplus (M) Sdn Bhd have in the registry?
The registry currently lists 10 devices for Careplus (M) Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Careplus (M) Sdn Bhd's devices?
Among its 10 most recently registered devices, Careplus (M) Sdn Bhd has devices listed in FDA 510(k) (10 devices).
What risk classes do Careplus (M) Sdn Bhd's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Careplus (M) Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Careplus (M) Sdn Bhd in the registry?
The most recently registered devices listed for Careplus (M) Sdn Bhd include Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein), ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs and POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored)..