Home / 510(k) Clearances / K960999

510(k) K960999

ISOLATION GOWN by Copioumed Intl., Inc. — Product Code FYC

K960999 is an FDA 510(k) premarket notification submitted by Copioumed Intl., Inc. for the device "ISOLATION GOWN". The FDA issued a decision of Substantially Equivalent on December 30, 1996. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Copioumed Intl., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1996
Date Received
March 12, 1996
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 Copioumed Intl., Inc.

  • K030927 — POWDERED VINYL EXAM GLOVES, WHITE (April 17, 2003)
  • K021961 — POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE (July 2, 2002)
  • K021743 — (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW (June 10, 2002)
  • K972624 — POLY (VINYL) EXAM GLOVE, POWDER-FREE (November 6, 1997)
  • K971316 — POLY (VINYL) EXAM GLOVE, POWDERED (August 27, 1997)
  • K965237 — NURSES BOUFFANT CAP (August 27, 1997)
  • K961342 — SHOE COVER, NON-STERILE (December 30, 1996)

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