# Encompass Industries Sdn. Bhd.

- Location (FDA's records): Kemaman, MY
- FDA decisions: 3 (2019–2025): 3 510(k) clearances
- Product codes: LZA (2), LZC (1)
- 510(k) review time since 2016: median 152 days, against 111 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Comfort Rubber Gloves Industries Sdn. Bhd.: 1 (https://510kreport.com/company/comfort-rubber-gloves-industries-sdn-bhd)
- Ansell Healthcare Products, LLC: 1 (https://510kreport.com/company/ansell-healthcare-products)

## Recent decisions
- K250342: Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl (Jul 8, 2025)
- K220609: Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) (May 27, 2022)
- K183562: Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs (Oct 23, 2019)

Source page: https://510kreport.com/company/encompass-industries-sdn-bhd