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510(k) K210780

Device
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Applicant
Shandong Shangwei Medical Products Co.,Ltd
510(k) number
K210780
Product code
LYZ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-05-14
Date received
2021-03-15
Regulation
880.6250
Classification name
Vinyl Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Li Hua
Address
North Rd., Fumin Ave., Qinghe St., Caoxian County Heze CN 274400 274400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LYZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.2026-04-07
K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.2025-10-27
K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.2025-08-28
K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.2024-05-20
K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.2023-03-25
K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation2023-02-06
K220992Disposable Powder Free Vinyl Exam Glove, Black/Blue/PurpleEver Global (Vietnam) Enterprise Corporation2022-10-19
K223008Disposable Vinyl Examination GlovesJiangxi Handspro Products Solutions Co., Ltd.2022-10-08
K222442DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)Anhui Bytech Medical Supplies Co., Ltd.2022-09-28
K220055Disposable, vinyl examination gloves, YellowDezhou Hengchang Medical Technology Co., Ltd.2022-08-25
K220469Disposable Vinyl Examination GloveChifeng Huawei Medical Science&Technology Co., Ltd.2022-06-16
K220240Vinyl Co-Polymer Powder-free Examination Gloves, BlackGrand Work Plastic Products Co., Ltd.2022-03-31
K213634Vinyl/Nitrile Blend Exam GloveDezhou Hengchang Medical Technology Co., Ltd.2022-02-18
K213625Vinyl Examination GlovesDezhou Hengchang Medical Technology Co., Ltd.2022-02-17
K212011Vinyl Powder Free Examination GloveTop Glove Vietnam Company Limited2022-02-14

Legacy Summary#

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FDA Review#

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