510(k) clearances

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

Xingyu Medical Tech Co., Ltd. · General Hospital

K240629Substantially EquivalentTraditionalLZA
Open FDA's page for this record
Third party flag
N
City
Weifang
Advisory committee description
General Hospital
Address 1
# 2189 Yaoqian Rd., Gaomi Economic Development Zone,
Address 2
Weifang City, Shandong Province
Statement or summary
Summary
Product code
LZA
Applicant
Xingyu Medical Tech Co., Ltd.
Decision date
2024-05-28
Decision code
SESE
Country code
CN
Device name
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Advisory committee
HO
Contact
Carrie Lee
K number
K240629
Date received
2024-03-06
Review advisory committee
HO
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Polymer Patient Examination Glove
Medical specialty description
General Hospital
Regulation number
880.6250
Device class
1
Registration number
3009474977, 2939388, 3010363542, 3004113569, 3038185756, 8041005, 3010811068, 3023272672, 3003958472, 3030086065, 3004111573, 3043226252, 3044026004, 3042940407, 3021394840, 3010402691, 3004168786, 3024755882, 3022953895, 2087418, 2434008, 3021015522, 3020984755, 8040614, 3015335977, 9613998, 3013565389, 3036774599, 3005022483, 3009429841, 3008058446, 3017610877, 3014847584, 3018779144, 3012304897, 3013998568, 3030582179, 3008496560, 3011209798, 3028652705 +348 more
FEI number
3009474977, 2939388, 3010363542, 3004113569, 3038185756, 3010811068, 3023272672, 1000154563, 3003958472, 3002808366, 3030086065, 3430, 3004111573, 3043226252, 3044026004, 3042940407, 3021394840, 3010402691, 3004168786, 3024755882, 3022953895, 2434008, 3021015522, 3002677549, 3020984755, 3015335977, 3003045222, 3013565389, 3036774599, 3005022483, 3009429841, 3008058446, 3017610877, 3014847584, 3018779144, 3012304897, 3013998568, 3030582179, 3008496560, 3011209798 +348 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.