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510(k) K213177

Plus Medical Cover Gown by Foshan Nanhai Plus Medical Co, Ltd. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2022
Date Received
September 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Foshan Nanhai Plus Medical Co, Ltd.

  • K222480 — Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) (November 14, 2022)
  • K211036 — Plus Medical Chemotherapy Gown (May 4, 2022)
  • K212698 — Plus Medical Isolation Gown Level 3 (March 2, 2022)
  • K212610 — Surgical Face Mask (January 26, 2022)
  • K210143 — Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) (July 22, 2021)
  • K133075 — Plus Surgical Gowns (EO Sterilized), PMGB-XXX (June 24, 2015)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)

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