510(k) clearances

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs

Lingshi Hongruida Health Protection Technology Co., Ltd. · General Hospital

K243959Substantially EquivalentTraditionalLZC
Open FDA's page for this record
Third party flag
N
City
Jinzhong
Advisory committee description
General Hospital
Address 1
Yangjiayuan, Liangdu Town, Lingshi County
Statement or summary
Summary
Product code
LZC
Zip code
031300
Applicant
Lingshi Hongruida Health Protection Technology Co., Ltd.
Decision date
2025-02-24
Decision code
SESE
Country code
CN
Device name
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
Advisory committee
HO
Contact
Chai Tinglong
K number
K243959
Date received
2024-12-23
Review advisory committee
HO
Postal code
031300
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Medical Glove, Specialty
Medical specialty description
General Hospital
Regulation number
880.6250
Device class
1
Registration number
2939388, 3010363542, 9616088, 1319302, 3038185756, 3013037032, 3013298431, 3004553390, 3004122598, 3012441043, 3013034812, 3020521811, 3002661124, 2437780, 3004995451, 8041005, 3015058854, 3014421917, 3010830834, 3002806603, 3003851058, 3023272672, 9617453, 8041150, 3003958472, 1055236, 3008298053, 3007327603, 3010195579, 3007407626, 3013681444, 3019840054, 3005568780, 3010864832, 9680466, 9611959, 3044026004, 3038284237, 3024897455, 3042940407 +244 more
FEI number
2939388, 3010363542, 1319302, 3038185756, 3013037032, 3013298431, 3004553390, 3004122598, 3012441043, 3013034812, 3002806565, 3020521811, 3002661124, 3004995451, 3015058854, 3014421917, 3002806603, 3002808507, 3023272672, 3003851058, 3003189428, 3003958472, 3002808366, 3008298053, 3007327603, 3010195579, 1000124109, 3007407626, 3013681444, 3019840054, 3002807146, 3000206435, 3044026004, 3038284237, 3001236905, 3024897455, 3015422337, 3042940407, 3006003617, 3001124136 +244 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.