510(k) clearances

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)

Sri Trang Gloves (Thailand) Public Company Limited · General Hospital

K232614Substantially EquivalentAbbreviatedLZA
Open FDA's page for this record
Third party flag
N
City
Hatyai
Advisory committee description
General Hospital
Address 1
10 Soi 10 Phetkasem Rd.
Statement or summary
Statement
Product code
LZA
Zip code
90110
Applicant
Sri Trang Gloves (Thailand) Public Company Limited
Decision date
2024-05-13
Decision code
SESE
Country code
TH
Device name
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
Advisory committee
HO
Contact
Jarinya Jirojkul
K number
K232614
Date received
2023-08-28
Review advisory committee
HO
Postal code
90110
Decision description
Substantially Equivalent
Clearance type
Abbreviated
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.