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510(k) K971917

KENTRON'S ISOLATION GOWN by Kentron Health Care, Inc. — Product Code FYC

K971917 is an FDA 510(k) premarket notification submitted by Kentron Health Care, Inc. for the device "KENTRON'S ISOLATION GOWN". The FDA issued a decision of Substantially Equivalent on September 19, 1997. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Kentron Health Care, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1997
Date Received
May 23, 1997
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 Kentron Health Care, Inc.

  • K030693 — KENTEX DISPOSABLE VAGINAL SPECULUM (August 27, 2003)
  • K972410 — IMPERVIOUS ISOLATION GOWN (September 19, 1997)
  • K953465 — KENTEMP (December 15, 1995)
  • K953914 — KENTEX (November 6, 1995)
  • K953830 — KENSORB (October 3, 1995)

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