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510(k) K923188

DYNASTY IMPERVIOUS ISOLATION J-SUIT by Dynatech Medical Products — Product Code FYC

K923188 is an FDA 510(k) premarket notification submitted by Dynatech Medical Products for the device "DYNASTY IMPERVIOUS ISOLATION J-SUIT". The FDA issued a decision of Substantially Equivalent on January 29, 1993. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Dynatech Medical Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1993
Date Received
June 30, 1992
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 Dynatech Medical Products

  • K923187 — IMPERVIOUS ISOLATION SHOE COVERS (January 29, 1993)
  • K922234 — DYNASTY ISOLATION GOWN (August 11, 1992)
  • K893520 — DR. BOO LATEX EXAMINATION GLOVES (August 21, 1989)
  • K770730 — PUMP, INFUSION, DYNATECH/HANDLEY (July 11, 1977)

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