Data / Medical devices / Malaysia / Encompass Industries Sdn. Bhd.
Encompass Industries Sdn. Bhd.: FDA-registered device maker in KEMAMAN Terengganu, Malaysia, 5 510(k) clearances
Encompass Industries Sdn. Bhd. is registered with the FDA (registration 3014384460) in KEMAMAN Terengganu, Malaysia. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 27, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014384460
- Address
- Lot 18256, Kawasan Perindustrian Lot Q Kertih Bio-Polymer Park, KEMAMAN Terengganu, Malaysia, 24300
- Owner or operator
- ENCOMPASS INDUSTRIES SDN. BHD. (10057400)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- April 10, 2018
- 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 | 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, Repackager or relabeler | accessdata.fda.gov |
| Powder-Free Polychloroprene Patient Examination Glove | OPC | 1 | Contract manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Contract 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 27, 2022 | K220609 | Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) | LZA | Substantially Equivalent | Encompass Industries Sdn. Bhd. | accessdata.fda.gov |
| October 23, 2019 | K183562 | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Encompass Industries Sdn. Bhd. | accessdata.fda.gov |
| May 2, 2012 | K120184 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED | LZA | Substantially Equivalent | Encompass Medical Supplies Inc Limited | accessdata.fda.gov |
| May 15, 2007 | K070861 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Hong Xin Rubber Products Co., Ltd. | accessdata.fda.gov |
| August 30, 1999 | K992223 | HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Pamitex Industries Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Surgeon'S Gloves
- All makers of Latex Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Powder-Free Polychloroprene Patient Examination Glove
Updated May 27, 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.