# Semperit Investments Asia Pte, Ltd.

- Location (FDA's records): Singapore, SG
- FDA decisions: 4 (2017–2023): 4 510(k) clearances
- Product codes: LZA (3), KGO (1)
- 510(k) review time since 2016: median 212 days, against 118 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 4 (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
- Siam Sempermed Corp., Ltd.: 1 (https://510kreport.com/company/siam-sempermed)
- Kossan International Sdn Bhd: 1 (https://510kreport.com/company/kossan-international-sdn-bhd)
- Semperit Technische Produkte Gesellshaft: 1 (https://510kreport.com/company/semperit-technische-produkte-gesellshaft)

## Firms that cite its devices most
- Anhui Powerguard Technology Co., Ltd.: 1 (https://510kreport.com/company/anhui-powerguard-technology)
- Shandong Xingyu Gloves Co., Ltd.: 1 (https://510kreport.com/company/shandong-xingyu-gloves)
- Harps Europe Manufacturing GmbH: 1 (https://510kreport.com/company/harps-europe-manufacturing)

## Its most-cited devices
- K223903: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) (2023), cited by 2
- K171378: Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs (2017), cited by 1
- K160781: Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves (2017), cited by 1

## Recent decisions
- K223903: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) (Jan 27, 2023)
- K183441: Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (Oct 4, 2019)
- K171378: Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs (Sep 14, 2017)
- K160781: Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves (May 2, 2017)

Source page: https://510kreport.com/company/semperit-investments-asia