Data / Medical devices / Malaysia / Careglove Global Sdn Bhd
Careglove Global Sdn Bhd: FDA-registered device maker in Seremban Negeri Sembilan, Malaysia, 6 510(k) clearances
Careglove Global Sdn Bhd is registered with the FDA (registration 3014164734) in Seremban Negeri Sembilan, Malaysia. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014164734
- Address
- Lot 17479, Lorong Senawang 3/2, Off Jln Senawang 3, Senawang Ind Estate, Seremban Negeri Sembilan, Malaysia, 70450
- Owner or operator
- Careglove Global Sdn Bhd (10051431)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 10, 2017
- Registered through
- 2026
- Brand names listed
- 6102 - Formula One Latex Exam Glove - S - NS, 6103 - Formula One Latex Exam Glove - Unisize - NS, 6104 - Formula One Latex Exam Glove - L - NS, 6202 - Ultracare Latex Exam Glove - S - NS, 6203 - Ultracare Latex Exam Glove - Unisize - NS, 6204 - Ultracare Latex Exam Glove - L - NS, Ambithix, CR-MLC - Formula 1 - Pdr - Lg and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2023 | K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | LZA | Substantially Equivalent | Careglove Global Sdn. Bhd. | accessdata.fda.gov |
| September 9, 2022 | K220859 | Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) | LZA | Substantially Equivalent | Careglove Global Sdn. Bhd. | accessdata.fda.gov |
| January 9, 2022 | K211666 | Powder Free Nitrile Examination Gloves, Blue Chemotest | LZA | Substantially Equivalent | Careglove Global Sdn. Bhd. | accessdata.fda.gov |
| December 30, 2019 | K190241 | Sterile Latex Surgical Glove, Powder Free | KGO | Substantially Equivalent | Careglove Global Sdn. Bhd. | accessdata.fda.gov |
| September 26, 2017 | K172015 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) | LZA | Substantially Equivalent | Careglove Global Sdn. Bhd. | accessdata.fda.gov |
| May 23, 2017 | K161833 | LATEX EXAMINATION GLOVE POWDER FREE | LYY | Substantially Equivalent | Careglove Global Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Surgeon'S Gloves
Updated May 15, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.