ClearanceBrief
510(k) K113707 ยท KGO Surgeon'S Gloves

STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING

ApplicantCardinal Health-Medical Products and Services, Waukegan IL, US
DecisionSubstantially Equivalent, Apr 27, 2012
ReceivedDec 16, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K113707

DateFirm and productCodeLinked 510(k)
Oct 31, 2018Cardinal Health 200, LLC
Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personne
Terminated
KGONone listed
Oct 31, 2018Cardinal Health 200, LLC
Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personn
Terminated
KGONone listed
Oct 31, 2018Cardinal Health 200, LLC
Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operati
Terminated
KGONone listed
Oct 31, 2018Cardinal Health 200, LLC
Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personne
Terminated
KGONone listed
Oct 31, 2018Cardinal Health 200, LLC
Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personne
Terminated
KGONone listed
Oct 31, 2018Cardinal Health 200, LLC
Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personne
Terminated
KGONone listed
Oct 31, 2018Cardinal Health 200, LLC
Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personne
Terminated
KGONone listed
Oct 31, 2018Cardinal Health 200, LLC
Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personne
Terminated
KGONone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.