# Smart Glove Corp. Sdn Bhd

- Location (FDA's records): Klang Selangor, MY
- FDA decisions: 32 (1998–2022): 32 510(k) clearances
- Names in FDA's records: Smart Glove Corp. Sdn Bhd (27); Smart Glove Corporation Sdn. Bhd. (5)
- Product codes: LZA (19), LYY (8), KGO (5)
- 510(k) review time since 2016: median 195 days, against 194 for FDA's reviews in the same codes and years (0 of 5 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (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 that cite its devices most
- Northstar Healthcare Holdings: 3 (https://510kreport.com/company/northstar-healthcare-holdings)
- Careglove Global Sdn. Bhd.: 1 (https://510kreport.com/company/careglove-global-sdn-bhd)
- Riverstone Resources Sdn Bhd: 1 (https://510kreport.com/company/riverstone-resources-sdn-bhd)

## Its most-cited devices
- K974907: Nitrile Pre-Powdered Examination Gloves (1998), cited by 1
- K060724: Powder Free Nitrile Examination Glove (Black and Gray) (2006), cited by 1
- K171743: Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves (2017), cited by 1
- K081466: Sterile, Powder Free Nitrile Examination Gloves, Blue (2008), cited by 1
- K050122: Powder Free Nitrile Examination Glove (Blue) (This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole) (2005), cited by 1

## Recent decisions
- K213373: Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Mar 10, 2022)
- K183280: PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs (Jul 26, 2019)
- K181047: Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested  for Use with Chemotherapy Drugs (Jan 9, 2019)
- K180221: Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical  Gloves - Tested for Use with Chemotherapy Drugs (Aug 8, 2018)
- K171743: Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves (Nov 17, 2017)
- K091147: Powder Free Nitrile Examination Glove (Blue) (Jul 27, 2009)
- K082370: Powder Free Nitrile Examination Glove (Blue) (Oct 17, 2008)
- K081466: Sterile, Powder Free Nitrile Examination Gloves, Blue (Jul 30, 2008)

Source page: https://510kreport.com/company/smart-glove-sdn-bhd