CONVERTORS SMS POLYOLEFIN GOWN— 510(k) K020593
Substantially EquivalentAllegiance Healthcare Corp.
FDA 510(k) clearance K020593 for CONVERTORS SMS POLYOLEFIN GOWN, Substantially Equivalent on 2002-03-18. Applicant: Allegiance Healthcare Corp.. Device class: 2.
Clearance details
- Applicant
- Allegiance Healthcare Corp.
- 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
- Special
- Location
- Mcgaw Park, 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 Allegiance Healthcare Corp.
view all- K023673 — AIRLIFE DEMAND NASAL CANNULA
- K023419 — TRILAMINATE DRAPES/TIBURON
- K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES
- K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
- K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Recalls naming K020593
K-number listed on FDA's recall record- Z-0372-2022 — Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
- Z-0373-2022 — Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
- Z-0374-2022 — Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
- Z-0375-2022 — RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
- Z-0376-2022 — RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
- Z-0377-2022 — RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
- Z-0378-2022 — RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
- Z-1009-2020 — AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC
- Z-1010-2020 — AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
- Z-1011-2020 — AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
- Z-1012-2020 — AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
- Z-1013-2020 — AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
- Z-1014-2020 — ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
- Z-1022-2020 — ROYALSILK LARGE, Gown. Item Code 9518
- Z-1023-2020 — ROYALSILK 2XLARGE, Gown. Item Code 9578
- Z-1024-2020 — ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
- Z-1025-2020 — AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
- Z-1026-2020 — AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
- Z-1027-2020 — ROYALSILK XLARGE, Gown. Item Code 9548
- Z-1034-2020 — AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020593.
Data sourced from openFDA. This site is unofficial and independent of the FDA.