K231567

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)

510(k) number: K231567
Device name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)
Applicant: Better Care Plastic Technology Co., Ltd. CN
Product code: LZA — Polymer Patient Examination Glove
Decision date: 2023-10-04
Date received: 2023-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

510(k) Summary (official FDA PDF): K231567.pdf

Official FDA record: K231567

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.