# Maxter Glove Manufacturing Sdn Bhd

- Location (FDA's records): Meru, Klang, MY
- FDA decisions: 9 (2001–2018): 9 510(k) clearances
- Product codes: LYY (3), LZC (2), LZA (2), KGO (2)
- 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
- Wrp Asia Pacific Sdn. Bhd.: 1 (https://510kreport.com/company/wrp-asia-pacific-sdn-bhd)
- Kossan International Sdn Bhd: 1 (https://510kreport.com/company/kossan-international-sdn-bhd)

## Recent decisions
- K172864: Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (May 2, 2018)
- K151390: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (May 2, 2016)
- K113100: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Feb 6, 2012)
- K040176: Maxter Powder Free Nitrile Medical Examination Gloves (Feb 24, 2004)
- K032501: Maxter Sterile Powder Free Surgical Gloves (Oct 17, 2003)
- K032467: Maxter Sterile Powdered Latex Surgical Gloves (Oct 10, 2003)
- K013498: Chlorinated Powder Free Latex Medical Examination Gloves with Protein Labeling Claim (50 Micrograms or Less) (Jan 17, 2002)
- K013554: Polymer Coated Powder Free Latex Medical Examination Gloves with Protein Labeling Claim (50 Micrograms or Less) (Jan 17, 2002)

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