Documento fuente o registro público
FDA 510(k) K211667 — Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
FDA 510(k) index record K211667. Device: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile). Applicant as listed: Changzhou Universal Medical Equipment Co., Ltd.. Decision date: 2021-09-23.
Fuente
"device_name": "Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)"
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Automated FDA record verification
2026-10-20
2026-10-31
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FDA 510(k) public index record K211667.
Device name: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile). Applicant as listed: Changzhou Universal Medical Equipment Co., Ltd..
Decision date: 2021-09-23. Decision wording: Substantially Equivalent.
Product code: LAZ. Regulation: 21 CFR 862.3280. Medical specialty: Clinical Toxicology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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