# Spi Gloves Sdn. Bhd.

- Location (FDA's records): Ipoh 30450, MY
- FDA decisions: 7 (2005–2005): 7 510(k) clearances
- Product codes: LYY (4), LZA (3)
- Predicates its devices cite: 0 (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 that cite its devices most
- Alatech Healthcare, LLC: 1 (https://510kreport.com/company/alatech-healthcare)

## Its most-cited devices
- K050527: Powdered Latex Examination Gloves with Protein Labeling Claim (Contains 200 Micrograms or Less of Total Water Extractabl (2005), cited by 1

## Recent decisions
- K050526: Polymer Coated Online Chlorinated Powder Free Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or (Dec 6, 2005)
- K050528: Powder Free Nitrile Examination Gloves (Blue,White,Violet,Pink,Green,Black) (May 19, 2005)
- K050532: Chlorinated Powder Free Latex Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or Less of Total WA (Apr 14, 2005)
- K050531: Powdered Nitrile Examination Gloves (Blue,White) (Mar 18, 2005)
- K050527: Powdered Latex Examination Gloves with Protein Labeling Claim (Contains 200 Micrograms or Less of Total Water Extractabl (Mar 18, 2005)
- K050529: Polymer Coated Powder Free Latex Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or Less of Toter (Mar 16, 2005)
- K050530: Polymer Coated Powder Free Nitrile Examination Gloves (Blue,White,Violet, Pink,Green) (Mar 16, 2005)

Source page: https://510kreport.com/company/spi-gloves-sdn-bhd