510(k) clearances

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs

Anhui Intco Medical Products Co., Ltd. · General Hospital

K233598Substantially EquivalentTraditionalLZA
Open FDA's page for this record
Third party flag
N
City
Huaibei City
Advisory committee description
General Hospital
Address 1
# 6, Haitang S. Rd., Suixi Wuhu Modern Industrial Park
Address 2
Suixi County
Statement or summary
Summary
Product code
LZA
Zip code
235000
Applicant
Anhui Intco Medical Products Co., Ltd.
Decision date
2024-01-26
Decision code
SESE
Country code
CN
Device name
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
Advisory committee
HO
Contact
Max Li
K number
K233598
Date received
2023-11-09
Review advisory committee
HO
Postal code
235000
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
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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.