35g Standard SMMS Surgical Gown +6 more— 510(k) K221819
Substantially EquivalentWinner Medical Co., Ltd.
FDA 510(k) clearance K221819 for 35g Standard SMMS Surgical Gown +6 more, Substantially Equivalent on 2022-09-19. Applicant: Winner Medical Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- 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
- Applicant
- Winner Medical Co., Ltd.
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangdong, CN
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