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510(k) K945223

OREX ISOLATION GOWN by Thantex Specialties, Inc. — Product Code FYC

K945223 is an FDA 510(k) premarket notification submitted by Thantex Specialties, Inc. for the device "OREX ISOLATION GOWN". The FDA issued a decision of Substantially Equivalent on April 25, 1995. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Thantex Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1995
Date Received
October 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Thantex Specialties, Inc.

  • K970547 — ISOLYSER SDS SHARPS CONTAINER (July 18, 1997)
  • K961083 — OREX SURGEON'S VEST (August 23, 1996)
  • K942200 — ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (August 7, 1995)
  • K943626 — ISOLYSER SHARPS MANAGEMENT SYSTEM SMS (June 16, 1995)
  • K945755 — OREX(R) O.R EQUIPMENT DRAPES (May 25, 1995)
  • K944859 — OREX SURGICAL DRAPES (February 28, 1995)
  • K944827 — OREX SURGEON'S GOWN (February 28, 1995)
  • K943034 — OREX SHOE COVERS (January 2, 1995)
  • K942228 — OREX O.R. TOWEL (December 20, 1994)
  • K940765 — ISOLYSER (December 19, 1994)

Other clearances for product code FYC

  • K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI (May 16, 2024)
  • K230135 — Copioumed Chemotherapy Isolation Gown (October 4, 2023)
  • K223467 — Disposable Isolation Gown (February 10, 2023)
  • K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (February 8, 2023)
  • K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (January 4, 2023)
  • K212717 — Paneffort AAMI Level 3 Isolation Gown (November 30, 2022)
  • K210414 — CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable G (October 21, 2022)
  • K214116 — AAMI4 Isolation Gown (October 11, 2022)
  • K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (August 12, 2022)
  • K220528 — Surgical Isolation Cover Gown (June 10, 2022)

FDA data resources