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FDA 510(k)

BIOTECH Nitrile Examination Gloves

K-Number: K202419 · 2021-04-16

ApplicantTk Hitech Technology Co., Ltd.
Decision Date2021-04-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOTECH Nitrile Examination Gloves is a medical device manufactured by Tk Hitech Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-04-16 under approval number K202419. 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 BIOTECH Nitrile Examination Gloves?

BIOTECH Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-04-16. It is manufactured by Tk Hitech Technology Co., Ltd.. The 510(k) number is K202419.

When was BIOTECH Nitrile Examination Gloves approved by the FDA?

BIOTECH Nitrile Examination Gloves received FDA 510(k) clearance on 2021-04-16, under approval number K202419.

What company makes BIOTECH Nitrile Examination Gloves?

BIOTECH Nitrile Examination Gloves is manufactured by Tk Hitech Technology Co., Ltd..

What is the FDA product code for BIOTECH Nitrile Examination Gloves?

The FDA product code for BIOTECH Nitrile Examination Gloves is 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.

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