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FDA 510(k)

Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink

K-Number: K161932 · 2016-11-28

ApplicantTerang Nusa Sdn Bhd
Decision Date2016-11-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink is a medical device manufactured by Terang Nusa Sdn Bhd. It received FDA 510(k) clearance on 2016-11-28 under approval number K161932. 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 Blue, Powder Free Polychloroprene Examination Glove Pink?

Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink is a medical device that received FDA 510(k) clearance on 2016-11-28. It is manufactured by Terang Nusa Sdn Bhd. The 510(k) number is K161932.

When was Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink approved by the FDA?

Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink received FDA 510(k) clearance on 2016-11-28, under approval number K161932.

What company makes Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink?

Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink is manufactured by Terang Nusa Sdn Bhd.

What is the FDA product code for Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink?

The FDA product code for Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink is LZA.

Related Clinical Trials

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Other Devices by Terang Nusa Sdn Bhd

K153510Powder Free Polychloroprene Examination Glove Green K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein

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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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