Disposable Nitrile Examination Gloves
K-Number: K203436 · 2021-04-28
Decision Date2021-04-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Disposable Nitrile Examination Gloves is a medical device manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd.. It received FDA 510(k) clearance on 2021-04-28 under approval number K203436. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Disposable Nitrile Examination Gloves?
Disposable Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-04-28. It is manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The 510(k) number is K203436.
When was Disposable Nitrile Examination Gloves approved by the FDA?
Disposable Nitrile Examination Gloves received FDA 510(k) clearance on 2021-04-28, under approval number K203436.
What company makes Disposable Nitrile Examination Gloves?
Disposable Nitrile Examination Gloves is manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd..
What is the FDA product code for Disposable Nitrile Examination Gloves?
The FDA product code for Disposable Nitrile Examination Gloves is LZA.
Related Clinical Trials
Other Devices by Shandong Zhushi Pharmaceutical Group Co., Ltd.
K210510Disposable Surgical Gown
K210643Disposable Surgical Face Mask
K210409Disposable Surgical Face Mask
K203454Infrared Thermometer
K203439Disposable Vinyl Examination Gloves
K212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle
Related Devices (Code: LZA)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.