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FDA 510(k)

Powder Free Polychloroprene Examination Glove Green

K-Number: K153510 · 2016-03-21

ApplicantTerang Nusa Sdn Bhd
Decision Date2016-03-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Polychloroprene Examination Glove Green is a medical device manufactured by Terang Nusa Sdn Bhd. It received FDA 510(k) clearance on 2016-03-21 under approval number K153510. 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 Powder Free Polychloroprene Examination Glove Green?

Powder Free Polychloroprene Examination Glove Green is a medical device that received FDA 510(k) clearance on 2016-03-21. It is manufactured by Terang Nusa Sdn Bhd. The 510(k) number is K153510.

When was Powder Free Polychloroprene Examination Glove Green approved by the FDA?

Powder Free Polychloroprene Examination Glove Green received FDA 510(k) clearance on 2016-03-21, under approval number K153510.

What company makes Powder Free Polychloroprene Examination Glove Green?

Powder Free Polychloroprene Examination Glove Green is manufactured by Terang Nusa Sdn Bhd.

What is the FDA product code for Powder Free Polychloroprene Examination Glove Green?

The FDA product code for Powder Free Polychloroprene Examination Glove Green is LZA.

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Other Devices by Terang Nusa Sdn Bhd

K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein

Related Devices (Code: 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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