ClearanceBrief
510(k) K020593 ยท FYA Gown, Surgical

CONVERTORS SMS POLYOLEFIN GOWN

ApplicantAllegiance Healthcare Corp., Mcgaw Park IL, US
DecisionSubstantially Equivalent, Mar 18, 2002
ReceivedFeb 22, 2002
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K020593

DateFirm and productCodeLinked 510(k)
Nov 2, 2021Cardinal Health
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Open, Classified		 FYANone listed
Nov 2, 2021Cardinal Health
Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Open, Classified		 FYANone listed
Nov 2, 2021Cardinal Health
Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
Open, Classified		 FYANone listed
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Open, Classified		 FYANone listed
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Open, Classified		 FYANone listed
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Open, Classified		 FYANone listed
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Open, Classified		 FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
ROYALSILK LARGE, Gown. Item Code 9518
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
ROYALSILK 2XLARGE, Gown. Item Code 9578
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
ROYALSILK XLARGE, Gown. Item Code 9548
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL
Terminated		 FYANone listed
Jan 24, 2020Cardinal Health
AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511
Terminated		 FYANone listed

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