Biodegradable Nitrile Powder Free Examination Glove (Blue)
K-Number: K173509 · 2018-08-17
Device Summary
Frequently Asked Questions
What is the Biodegradable Nitrile Powder Free Examination Glove (Blue)?
Biodegradable Nitrile Powder Free Examination Glove (Blue) is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Hartalega Sdn Bhd. The 510(k) number is K173509.
When did Biodegradable Nitrile Powder Free Examination Glove (Blue) receive FDA 510(k) clearance?
Biodegradable Nitrile Powder Free Examination Glove (Blue) received FDA 510(k) clearance on 2018-08-17, under 510(k) number K173509.
Who is the listed applicant for Biodegradable Nitrile Powder Free Examination Glove (Blue)?
The FDA 510(k) record lists Hartalega Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Biodegradable Nitrile Powder Free Examination Glove (Blue)?
The FDA product code for Biodegradable Nitrile Powder Free Examination Glove (Blue) is LZA.
Other records listing Hartalega Sdn Bhd 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.
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.
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.