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510(k) K160361

PRIMAGARD Isolation Gown (AAMI PB70 Level 3) by Primed Medical Products, Inc. — Product Code FYC

K160361 is an FDA 510(k) premarket notification submitted by Primed Medical Products, Inc. for the device "PRIMAGARD Isolation Gown (AAMI PB70 Level 3)". The FDA issued a decision of Substantially Equivalent on November 4, 2016. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Primed Medical Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2016
Date Received
February 9, 2016
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 Primed Medical Products, Inc.

  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (October 7, 2024)
  • K240286 — PRIMED Surgical Masks and PRIMED Procedure Masks (August 26, 2024)
  • K233777 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (May 24, 2024)
  • K213427 — PRIMED Pediatric Facemask (November 22, 2022)
  • K092012 — PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL (September 25, 2009)
  • K081633 — PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS (August 11, 2008)

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