Atlas FDA

Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve

FDA 510(k) clearance K193327 · decided 2020-03-20

Clearance details

K-number
K193327
Device name
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
Applicant
Cardinal Health200, LLC
Decision
Substantially Equivalent
Date received
2019-12-02
Decision date
2020-03-20
Days to decision
109 days
Clearance type
Traditional
Product code
FYA
Device class
2
Regulation number
878.4040
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Waukegan, IL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (K252575)New York Embroidery Studio (NYES)2026-06-04
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (K260725)Hindernis DE Mexico, S.A.P.I. DE C.V.2026-05-12
Cardinal Health™ Poly Reinforced Surgical Gown (K253243)Cardinal Health 200, LLC2026-04-28
Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) (K253003)Hubei Xinxin Non-Woven Co., Ltd.2026-04-20
Copioumed AAMI 3 Surgical Gown (K251860)Copioumed International, Inc.2026-02-26
Henan Yadu Level 4 Surgical Gowns (Reinforced) (K252301)Yadu Medical (Henan) Co., Ltd.2026-02-04
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (K250564)Yadu Medical (Henan) Co., Ltd.2025-12-03
ViVi® Toga Premium (K243522)Thi Total Healthcare Innovation GmbH2025-05-30
Dream Medi Sterile Surgical Gown (SurgicalGownUL) (K242937)Dae Myung Chemical Co., Ltd. (Vietnam)2025-05-05
Medline Level 4 Surgical Gown with Breathable Sleeves (K242844)Medline Industries, LP2025-02-26

Recalls involving this device

RecordFirmDate
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, recall (Z-0897-2026)Cardinal Health 200, LLC2025-12-11