Decision Date2017-03-31
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Top Quality Glove Sdn. Bhd. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K162626. 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 THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE?
THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Top Quality Glove Sdn. Bhd. The 510(k) number is K162626.
When did THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE receive FDA 510(k) clearance?
THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE received FDA 510(k) clearance on 2017-03-31, under 510(k) number K162626.
Who is the listed applicant for THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE?
The FDA 510(k) record lists Top Quality Glove Sdn. Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE?
The FDA product code for THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE 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.