510(k) clearances

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)

Basic Medical Technology, Inc. · General Hospital

K243792Substantially EquivalentTraditionalLZA
Open FDA's page for this record
Third party flag
N
City
Ontario
Advisory committee description
General Hospital
Address 1
5300 Concours St.
Statement or summary
Summary
Product code
LZA
Zip code
91764
Applicant
Basic Medical Technology, Inc.
Decision date
2025-02-18
Decision code
SESE
Country code
US
Device name
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)
Advisory committee
HO
Contact
John Zhao
K number
K243792
State
CA
Date received
2024-12-10
Review advisory committee
HO
Postal code
91764
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.