# Top Calibre Sdn Bhd

- Location (FDA's records): Shah Alam, MY
- FDA decisions: 5 (2012–2014): 5 510(k) clearances
- Product codes: LYY (4), LZA (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 1 (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
- Wear Safe Malaysia Sdn. Bhd.: 2 (https://510kreport.com/company/wear-safe-malaysia-sdn-bhd)
- Hartalega Sdn Bhd: 1 (https://510kreport.com/company/hartalega-sdn-bhd)
- Wrp Asia Pacific Sdn. Bhd.: 1 (https://510kreport.com/company/wrp-asia-pacific-sdn-bhd)
- Perusahaan Getah Asas Sdn. Bhd.: 1 (https://510kreport.com/company/perusahaan-getah-asas-sdn-bhd)

## Firms that cite its devices most
- A1 Glove Sdn Bhd: 1 (https://510kreport.com/company/a1-glove-sdn-bhd)

## Its most-cited devices
- K112612: Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim (2012), cited by 1

## Recent decisions
- K133949: Powder Free Nitrile Patient Examination Glove,Blue and Orange Colored,Non-Sterile Tested for Use with Chemotherapy Drugs (Apr 8, 2014)
- K123819: Multiple Name (Mar 5, 2013)
- K120692: Latex Examination Gloves (Powder Free) (May 14, 2012)
- K120693: Latex Examination Gloves (Powdered) (May 8, 2012)
- K112612: Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim (Jan 18, 2012)

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