Data / Medical devices / Malaysia / Bergamot Sdn Bhd
Bergamot Sdn Bhd: FDA-registered device maker in KAJANG Selangor, Malaysia, 6 510(k) clearances
Bergamot Sdn Bhd is registered with the FDA (registration 3014743234) in KAJANG Selangor, Malaysia. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 20, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014743234
- Address
- No. 7 & 8, Jalan Sinaran 6 Kawasan Perindustrian Sinaran, KAJANG Selangor, Malaysia, 43000
- Owner or operator
- BERGAMOT SDN BHD (10079487)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- December 9, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| February 20, 2007 | K062527 | BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| July 10, 2001 | K011293 | POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES | LYY | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| July 26, 2000 | K001619 | MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) | LZA | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| July 26, 2000 | K001497 | MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) | LZA | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| May 22, 2000 | K000999 | MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
| March 2, 2000 | K993811 | MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE | LYY | Substantially Equivalent | Multisafe Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Accessory, Surgical Apparel
Updated February 20, 2007. 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.