Cardinal Health Non-Reinforced Surgical Gown— 510(k) K170762
Substantially EquivalentCardinal Health200, LLC
FDA 510(k) clearance K170762 for Cardinal Health Non-Reinforced Surgical Gown, Substantially Equivalent on 2017-06-09. Applicant: Cardinal Health200, LLC. Device class: 2.
Clearance details
- Applicant
- Cardinal Health200, LLC
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukegan, IL, US
Recent devices under product code FYA
view all- K260407 — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
- K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- K261949 — NYES Tuff Cuff L3 Disposable Gowns
- K252575 — Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
More clearances from Cardinal Health200, LLC
view all- K241780 — Cardinal Health Nitrile Exam Gloves
- K230838 — Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets
- K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110) +2 more
- K230028 — Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
- K201592 — Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
Recalls naming K170762
K-number listed on FDA's recall record- Z-1003-2020 — AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
- Z-1007-2020 — AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
- Z-1015-2020 — AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N
- Z-1016-2020 — AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
- Z-1018-2020 — AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
- Z-1019-2020 — AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC
- Z-1020-2020 — AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
- Z-1021-2020 — AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
- Z-1028-2020 — AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575
- Z-1029-2020 — AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
- Z-1030-2020 — AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
- Z-1031-2020 — AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995
- Z-1032-2020 — GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
- Z-1033-2020 — AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545
- Z-1037-2020 — AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
- Z-1038-2020 — AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
- Z-1039-2020 — AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170762.
Data sourced from openFDA. This site is unofficial and independent of the FDA.