Xianning Eco Medical Articles Co., Ltd.

FDA Regulatory Profile

Xianning Eco Medical Articles Co., Ltd. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Sep 8, 2017 · NAI
Latest 510(k)
Aug 19, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 8, 2017Xianning, ChinaDevicesNo Action Indicated (NAI)3008240985
Jul 24, 2014Xianning, ChinaDevicesNo Action Indicated (NAI)3008240985

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K210698ECOMA Level 2 Disposable Surgical Mask with Ear LoopsAug 19, 2021