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510(k) K882281

GOWN, ISOLATION, SURGICAL (FYC) by A Plus International, Inc. — Product Code FYC

K882281 is an FDA 510(k) premarket notification submitted by A Plus International, Inc. for the device "GOWN, ISOLATION, SURGICAL (FYC)". The FDA issued a decision of Substantially Equivalent on June 23, 1988. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. A Plus International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1988
Date Received
May 31, 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 A Plus International, Inc.

  • K213001 — Procedure Mask, Surgical Mask (May 11, 2022)
  • K102861 — SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINA (January 13, 2011)
  • K093169 — SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL G (November 12, 2009)
  • K031353 — SOLUTION FACE MASKS (June 19, 2003)
  • K882284 — SURGEONS CAP (June 23, 1988)
  • K882282 — SUIT, SURGICAL (June 23, 1988)
  • K882283 — BOUFFANT CAP (June 23, 1988)
  • K882280 — COVER, SHOE OPERATING ROOM (June 23, 1988)
  • K881396 — OPERATING ROOM TOWELS -STERILE & NON-STERILE (April 29, 1988)
  • K881395 — GAUZE AND LAP SPONGES -STERILE & NON-STERILE (April 28, 1988)

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