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510(k) K880484

SURGICAL GARMENTS by Greene International Corp. — Product Code FYC

K880484 is an FDA 510(k) premarket notification submitted by Greene International Corp. for the device "SURGICAL GARMENTS". The FDA issued a decision of Substantially Equivalent on June 27, 1988. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Greene International Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1988
Date Received
February 4, 1988
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 Greene International Corp.

  • K883827 — MASKS, VARIOUS TYPES OF SURGICAL MASKS (November 17, 1988)
  • K883828 — CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS (October 3, 1988)
  • K870617 — VARIOUS TYES OF SURGICAL GARMENTS (March 9, 1987)
  • K843075 — UTILITY SCISSORS DISPOSABLE ITEMS (September 5, 1984)
  • K843073 — FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP (August 24, 1984)
  • K843074 — DISPOS. & SPONGE FORCEPS PEAN ARTERY (August 17, 1984)
  • K842719 — STANDARD WHEELCHAIR (July 25, 1984)

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