Data / Medical devices / Malaysia / Cross Protection M Sdn Bhd
Cross Protection M Sdn Bhd: FDA-registered device maker in Klang Selangor, Malaysia, 3 510(k) clearances
Cross Protection M Sdn Bhd is registered with the FDA (registration 3008107579) in Klang Selangor, Malaysia. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 17, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008107579
- Address
- NO. 18, PERSIARAN ASTANA /KU 2 Bandar Bkt Raja, Klang Selangor, Malaysia, 41050
- Owner or operator
- CROSS PROTECTION M SDN BHD (10036184)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- April 21, 2011
- Registered through
- 2026
- Brand names listed
- Cross Protection, Cross Protection COLOR Latex Examination Gloves Powder Free, Cross Protection ResQ300 Plus Surgical Face Mask, Cross Protection Saliva Ejector, Cross Protection Saliva Ejector Tip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | 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 |
|---|---|---|---|---|---|---|
| August 17, 2022 | K212273 | Cross Protection ResQ300 Plus Surgical Face Mask | FXX | Substantially Equivalent | Cross Protection (M) Sdn Bhd | accessdata.fda.gov |
| December 2, 2009 | K093375 | KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) | LYY | Substantially Equivalent | Koon Seng Sdn Bhd | accessdata.fda.gov |
| July 14, 1997 | K970770 | LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Oon Corp. Resources | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Accessory, Surgical Apparel
- All makers of Mouthpiece, Saliva Ejector
- All makers of Mask, Surgical
Updated August 17, 2022. 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.