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510(k) K954747

NIOMED BARRIER GOWNS by Amerasia Corp. — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1996
Date Received
October 16, 1995
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 Amerasia Corp.

  • K955833 — NIOMED SURGICAL CAPS (March 15, 1996)
  • K954455 — NIOMED BOUFFANT CAPS (January 23, 1996)
  • K954454 — NIOMED SURGICAL HOOD (January 23, 1996)
  • K952937 — NIOMED NON-SKID SHOE COVERS (October 23, 1995)
  • K952897 — NIOMED SHOE COVERS (October 23, 1995)

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  • 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)
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