510(k) clearances

Disposable Vinyl Examination Gloves

Anqing Pukang Medical Technology Co., Ltd. · General Hospital

K241252Substantially EquivalentTraditionalLYZ
Open FDA's page for this record
Third party flag
Y
City
Anqing
Advisory committee description
General Hospital
Address 1
No 7 Haian Rd.
Statement or summary
Summary
Product code
LYZ
Zip code
246000
Applicant
Anqing Pukang Medical Technology Co., Ltd.
Decision date
2024-05-20
Decision code
SESE
Country code
CN
Device name
Disposable Vinyl Examination Gloves
Advisory committee
HO
Contact
Min Gao
K number
K241252
Date received
2024-05-03
Review advisory committee
HO
Postal code
246000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Vinyl Patient Examination Glove
Medical specialty description
General Hospital
Regulation number
880.6250
Device class
1
Registration number
3006787036, 2939388, 3004150701, 3010363542, 3015477649, 3007838093, 1319302, 2938651, 3004993527, 3020106122, 3014421917, 2029015, 3008261717, 3009099927, 3008384335, 1055236, 3007407626, 3012304513, 3015875006, 9611959, 3003896660, 3004168786, 9681151, 3009118264, 3029952429, 1417592, 3008388240, 3017953728, 3042129350, 3012421607, 2083656, 3011089435, 3016601021, 3034618336, 3014345238, 3011862887, 3006946173, 3011208584, 3015537296, 2517925 +94 more
FEI number
3006787036, 2939388, 3004150701, 3010363542, 3015477649, 3007838093, 1319302, 2938651, 3004993527, 1000160458, 3020106122, 3014421917, 3008261717, 3009099927, 3008384335, 1000124109, 3007407626, 3012304513, 3015875006, 3003792528, 3003896660, 3004168786, 3009118264, 1000137528, 3008875470, 3029952429, 1417592, 3008388240, 3017953728, 3042129350, 3002677549, 3012421607, 2083656, 3011089435, 3016601021, 3034618336, 3014345238, 3002166545, 3011862887, 3011208584 +94 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.