Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
K-Number: K192232 · 2019-11-08
Device Summary
Frequently Asked Questions
What is the Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)?
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Hartalega NGC Sdn. Bhd.. The 510(k) number is K192232.
When did Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) receive FDA 510(k) clearance?
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) received FDA 510(k) clearance on 2019-11-08, under 510(k) number K192232.
Who is the listed applicant for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)?
The FDA 510(k) record lists Hartalega NGC Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)?
The FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) is LZA.
Other records listing Hartalega NGC 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.