Decision Date1998-04-14
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
AR SAFE NITRILE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Alliance Rubber Products Sdn. Bhd.. It received FDA 510(k) clearance on 1998-04-14 under 510(k) number K980589. 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 AR SAFE NITRILE EXAMINATION GLOVES?
AR SAFE NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1998-04-14. The listed applicant is Alliance Rubber Products Sdn. Bhd.. The 510(k) number is K980589.
When did AR SAFE NITRILE EXAMINATION GLOVES receive FDA 510(k) clearance?
AR SAFE NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 1998-04-14, under 510(k) number K980589.
Who is the listed applicant for AR SAFE NITRILE EXAMINATION GLOVES?
The FDA 510(k) record lists Alliance Rubber Products Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AR SAFE NITRILE EXAMINATION GLOVES?
The FDA product code for AR SAFE 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.