# Mah Sing Healthcare Sdn. Bhd.

- Location (FDA's records): Kuala Lumpur, MY
- FDA decisions: 5 (2021–2025): 5 510(k) clearances
- Product codes: LZA (5)
- 510(k) review time since 2016: median 80 days, against 110 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 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
- Syntex Healthcare Products Co., Ltd.: 1 (https://510kreport.com/company/syntex-healthcare-products)
- Comfort Rubber Gloves Industries Sdn. Bhd.: 1 (https://510kreport.com/company/comfort-rubber-gloves-industries-sdn-bhd)
- Pastel Glove Sdn Bhd: 1 (https://510kreport.com/company/pastel-glove-sdn-bhd)
- Wrp Asia Pacific Sdn. Bhd.: 1 (https://510kreport.com/company/wrp-asia-pacific-sdn-bhd)

## Its most-cited devices
- K214110: Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs (2022), cited by 1

## Recent decisions
- K243694: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue (Jun 6, 2025)
- K230002: Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Mar 24, 2023)
- K223415: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Jan 26, 2023)
- K214110: Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs (Feb 19, 2022)
- K212535: Nitrile Powder Free Blue Examination Gloves, Non-Sterile (Dec 4, 2021)

Source page: https://510kreport.com/company/mah-sing-healthcare-sdn-bhd