50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown
FDA 510(k) clearance K192290 · decided 2020-04-30
Clearance details
- K-number
- K192290
- Device name
- 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown
- Applicant
- Xuchang Zhengde Environstar Medical Products Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-23
- Decision date
- 2020-04-30
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Xuchang, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.