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35g Standard SMMS Surgical Gown +6 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K221819
Identifiers
- 510(k) Number
- K221819 FDA 510(k)
- FDA Product Code
- FYA FDA 510(k)
- Models / Variants
- 35g Standard SMMS Surgical Gown FDA 510(k)35g Reinforced SMMS Surgical Gown FDA 510(k)43g Standard SMMS Surgical Gown FDA 510(k)43g Reinforced SMMS Surgical Gown FDA 510(k)50g Standard SMMS Surgical Gown FDA 510(k)50g Reinforced SMMS Surgical Gown FDA 510(k)BVB Surgical Gown FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
35g Standard SMMS Surgical Gown +6 more models by Winner Medical Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 7 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221819 | Class II | Active |
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Manufacturer
- Manufacturer
- Winner Medical Co., Ltd.
Sources (1)
- FDA 510(k) K221819 24 fields · synced Jun 18, 2026