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FDA 510(k)

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE

K-Number: K162626 · 2017-03-31

ApplicantTop Quality Glove Sdn. Bhd
Decision Date2017-03-31
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE is a medical device manufactured by Top Quality Glove Sdn. Bhd. It received FDA 510(k) clearance on 2017-03-31 under approval 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. It is manufactured by Top Quality Glove Sdn. Bhd. The 510(k) number is K162626.

When was THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE approved by the FDA?

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE received FDA 510(k) clearance on 2017-03-31, under approval number K162626.

What company makes THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE?

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE is manufactured by Top Quality Glove Sdn. Bhd.

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.

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