KP Protective Face Mask
Kp Trading Co., Ltd. · K243342
FDA-authorized Predetermined Change Control Plan
- Company
- Kp Trading Co., Ltd.
- 510(k)/De Novo #
- K243342
- Decision date
- 2025-12-22
- Panel
- General, Plastic Surgery
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Unknown
- Monitoring commitment
- Unknown
Other General, Plastic Surgery PCCPs
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- K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)Yadu Medical (Henan) Co., Ltd.2026-02-04Non-AIOther
- K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC2026-01-09Non-AIOther
- K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)Vitacore Industries, Inc.2025-09-17Non-AIOther
Want the monitoring teardown?
We read the PCCP for KP Protective Face Mask, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.