35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown— 510(k) K221819

Substantially Equivalent

Winner Medical Co., Ltd.

FDA 510(k) clearance K221819 for 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown, Substantially Equivalent on 2022-09-19. Applicant: Winner Medical Co., Ltd..

Clearance details

Applicant: Winner Medical Co., Ltd.
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2022-06-23
Decision date: 2022-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangdong, CN

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