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510(k) K133075

Plus Surgical Gowns (EO Sterilized), PMGB-XXX by Foshan Nanhai Plus Medical Co, Ltd. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2015
Date Received
September 30, 2013
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.

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  • 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)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)

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