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510(k) K223401

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) by Xiamen Probtain Medical Techology Co., Ltd. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2023
Date Received
November 9, 2022
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 Xiamen Probtain Medical Techology Co., Ltd.

  • K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (January 4, 2023)
  • K202954 — Disposable Surgical Mask (July 2, 2021)
  • K201893 — Disposable Surgical Mask (December 9, 2020)

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