ClearanceBrief
510(k) K001924 ยท KGO Surgeon'S Gloves

COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0

ApplicantAllegiance Healthcare Corp., Mcgraw Park IL, US
DecisionSubstantially Equivalent, Jul 14, 2000
ReceivedJun 23, 2000
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K001924

DateFirm and productCodeLinked 510(k)
Aug 28, 2020Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room person
Completed
KGONone listed
Aug 28, 2020Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room person
Completed
KGONone listed
Aug 28, 2020Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room person
Completed
KGONone listed
Aug 28, 2020Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room person
Completed
KGONone listed
Aug 28, 2020Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room person
Completed
KGONone listed
Aug 28, 2020Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room person
Completed
KGONone listed
Aug 28, 2020Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room person
Completed
KGONone listed
Aug 28, 2020Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room person
Completed
KGONone listed

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