Surgical, respirator, non-medical device (Ironbark creek investments)

TGA testing has identified that samples of the Respirators supplied under these ARTG entries did not comply with PFE requirements for respirators, along with a lack of homogeneity in the batches due to intra-batch variations.

The TGA’s testing results of several samples has also been confirmed by independent, third-party laboratory testing which also found that samples of the Respirators tested did not comply with PFE requirements for respirators.