FDA.report

510(k) K250496

Device
Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
Applicant
Zibo Shengkun Chemical Industry Co., Ltd.
510(k) number
K250496
Product code
LZA
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-07
Date received
2025-02-20
Regulation
880.6250
Classification name
Polymer Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Related Records

Applicant Contact

Contact
Yanfeng Zhang
Address
Lot 6, # 21 Qingtian Rd. Qilu Chemical Industrial Park Zibo CN 255414 255414

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

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