# Top Glove Sdn. Bhd.

- Location (FDA's records): Klang, Selangor, MY
- FDA decisions: 18 (1991–2026): 18 510(k) clearances
- Product codes: LYY (8), LZA (7), LYZ (2), KGO (1)
- 510(k) review time since 2016: median 205 days, against 103 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (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: 1 (https://510kreport.com/company/northstar-healthcare-holdings)
- Comfort Rubber Gloves Industries Sdn. Bhd.: 1 (https://510kreport.com/company/comfort-rubber-gloves-industries-sdn-bhd)

## Its most-cited devices
- K192111: Biodegradable Nitrile Examination Powder Free Glove, Green (2020), cited by 1
- K932521: Powderfree Latex Examination Gloves (1994), cited by 1

## Recent decisions
- K262542: Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim (Sep 9, 2026)
- K192111: Biodegradable Nitrile Examination Powder Free Glove, Green (Sep 3, 2020)
- K193150: Latex Examination Powder Free Glove, Aloe Vera (Jun 5, 2020)
- K172923: Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue (Apr 26, 2018)
- K171279: Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves (Oct 12, 2017)
- K122999: Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Nov 30, 2012)
- K023974: Aloe Vera & Vitamin E Powderfree Latex Examination Gloves (Feb 13, 2003)
- K021855: Top Glove Powderfree Latex Examination Glove with Protein Labelling Claims (50 Micrograms or Less) (Aug 5, 2002)

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