Data / Medical devices / Malaysia / Perusahaan Getah Asas Sdn. Bhd.
Perusahaan Getah Asas Sdn. Bhd.: FDA-registered device maker in JERAM Selangor, Malaysia, 6 510(k) clearances
Perusahaan Getah Asas Sdn. Bhd. is registered with the FDA (registration 3004553390) in JERAM Selangor, Malaysia. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 29, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004553390
- Address
- Lot 1365, Batu 17 Jalan Sungai Sembilang, JERAM Selangor, Malaysia, 45800
- Owner or operator
- PERUSAHAAN GETAH ASAS SDN BHD (8040956)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 1, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract 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 | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 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 |
|---|---|---|---|---|---|---|
| November 29, 2010 | K102790 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG | LZC | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| December 16, 2004 | K042805 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE | LZC | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| October 22, 2003 | K032374 | POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED | LZC | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| June 26, 2003 | K031591 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED | LZA | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| June 26, 2003 | K031414 | POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE | LYY | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| June 12, 2000 | K001529 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA | LYY | Substantially Equivalent | Perusahaan Getah Asas 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 Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated November 29, 2010. 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.