Dongguan Shin YI Healthcare Products Factory

FDA Regulatory Profile

Dongguan Shin YI Healthcare Products Factory has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 1 compliance action on record.

Latest inspection
Jun 18, 2015 · OAI
Latest 510(k)
Aug 23, 2023

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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) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 18, 2015Dongguan, ChinaDevicesOfficial Action Indicated (OAI)3004829691
Aug 11, 2011Dongguan, ChinaDevicesVoluntary Action Indicated (VAI)3004829691

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
K230610Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104…Aug 23, 2023
K210372Disposable Surgical MaskJun 7, 2021