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510(k) K211765

Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown by Cardinal Health, LLC — Product Code FYA

K211765 is an FDA 510(k) premarket notification submitted by Cardinal Health, LLC for the device "Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown". The FDA issued a decision of Substantially Equivalent on November 23, 2021. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Cardinal Health, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2021
Date Received
June 8, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Cardinal Health, LLC

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  • K170198 — Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested f (June 15, 2017)
  • K160411 — Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating (July 25, 2016)
  • K160875 — Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with (July 11, 2016)
  • K153316 — Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coatin (May 12, 2016)
  • K122696 — POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) (January 31, 2013)
  • K121897 — PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES (July 27, 2012)
  • K120934 — PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTE (May 23, 2012)
  • K111878 — PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES (September 29, 2011)
  • K110272 — STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAP (June 8, 2011)

Other clearances for product code FYA

  • K261949 — NYES Tuff Cuff L3 Disposable Gowns (July 10, 2026)
  • K252575 — Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (June 4, 2026)
  • K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (May 12, 2026)
  • K253243 — Cardinal Health™ Poly Reinforced Surgical Gown (April 28, 2026)
  • K253003 — Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); (April 20, 2026)
  • K251860 — Copioumed AAMI 3 Surgical Gown (February 26, 2026)
  • K252301 — Henan Yadu Level 4 Surgical Gowns (Reinforced) (February 4, 2026)
  • K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (December 3, 2025)
  • K243522 — ViVi® Toga Premium (May 30, 2025)
  • K242937 — Dream Medi Sterile Surgical Gown (SurgicalGownUL) (May 5, 2025)

FDA data resources