Device product

Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients.

Z-0456-2019

December 28, 2016

Class II

Product summary

Firm: American Contract Systems, Inc.
Event: Event 80754
Status: Terminated
Classification: Class II
Quantity: 1,180 kits
Official record key: device-enforcement:Z-0456-2019

Official wording

Reason: Powdered Surgical Gloves are an FDA banned substance.

Code information: Tray Number (Powdered Glove code): MHCE23D (ANS5711104), MHAP41D (ANS7825), MHOC43C (ANS7825), MHPO42D (ANS7825), GVTH071 (ANS5711104), GVTK05L (ANS5711104), GVTK05M (ANS5711104), CXTR68D (ANS5711105), MDEY35H (BAX2D7202I), MDEY35I (BAX2D7202I), FHLV24 (ANS5711105, ANS5711101), LKCA02A (ANS5710503), WIDE32 (ANS7824), UTLU70F (ANS7825), FIOH02H (BAX2D7254)

Distribution pattern: US Distribution to states of: IL, MO, NE, and OH.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Powdered Surgical Gloves are an FDA banned substance.