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510(k) K023167

BREATHABLE SURGICAL GOWN by Allegiance Healthcare Corp. — Product Code FYA

K023167 is an FDA 510(k) premarket notification submitted by Allegiance Healthcare Corp. for the device "BREATHABLE SURGICAL GOWN". The FDA issued a decision of Substantially Equivalent on October 2, 2002. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Allegiance Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2002
Date Received
September 23, 2002
Clearance Type
Special
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 Allegiance Healthcare Corp.

  • K023673 — AIRLIFE DEMAND NASAL CANNULA (May 2, 2003)
  • K023419 — TRILAMINATE DRAPES/TIBURON (February 11, 2003)
  • K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES (January 15, 2003)
  • K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN (January 9, 2003)
  • K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (December 18, 2002)
  • K023425 — DRAPES WITH ABSORBENT REINFORCEMENT (November 6, 2002)
  • K022765 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 11, 2002)
  • K023170 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 9, 2002)
  • K012931 — GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM (August 20, 2002)
  • K020818 — POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS (July 5, 2002)

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