Decision Date2020-04-09
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl is the device name listed in this FDA 510(k) record. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K200539. 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 Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl?
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K200539.
When did Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl receive FDA 510(k) clearance?
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl received FDA 510(k) clearance on 2020-04-09, under 510(k) number K200539.
Who is the listed applicant for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl?
The FDA 510(k) record lists Sri Trang Gloves (Thailand) Public Company Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl?
The FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl is LZA.
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Other records listing Sri Trang Gloves (Thailand) Public Company Limited as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Related Devices (Code: LZA)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.