510(k) clearances

Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Cardinalhealth · General Hospital

K261749Substantially EquivalentTraditionalLZA
Open FDA's page for this record
Third party flag
N
City
Waukegan
Advisory committee description
General Hospital
Address 1
3651 Birchwood Dr.
Statement or summary
Statement
Product code
LZA
Zip code
60085
Applicant
Cardinalhealth
Decision date
2026-09-02
Decision code
SESE
Country code
US
Device name
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Advisory committee
HO
Contact
Vani Bala
K number
K261749
State
IL
Date received
2026-05-28
Review advisory committee
HO
Postal code
60085
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
3015335977, 3006157842, 3007707004, 1250045, 3004111573, 3005024094, 3026263452, 3009549523, 1058397, 3022543478, 3017509841, 3031288561, 3013998568, 3022538552, 3009055041, 3013565389, 3015384427, 3015727296, 1319302, 3003887292, 3032579548, 3011200663, 3007842555, 1222115, 3007220726, 3031590640, 9680710, 3005568780, 3038277359, 3021015522, 3017616393, 3010763223, 3030455652, 3011391433, 1420054, 2648727, 3009784353, 1055236, 1025972, 3008058446 +350 more
FEI number
3015335977, 3006157842, 3010862763, 3007707004, 1250045, 3004111573, 3005024094, 3026263452, 3008875470, 3009549523, 1000137528, 1030186, 3022543478, 1000112877, 3017509841, 3031288561, 3004360380, 3013998568, 3003564842, 3022538552, 3009055041, 3013565389, 3015384427, 3015727296, 1319302, 3003887292, 1833338, 3032579548, 3011200663, 3007842555, 3003158169, 1222115, 3007220726, 3031590640, 3038277359, 3021015522, 3003792528, 3017616393, 3010763223, 3030455652 +350 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.