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FDA 510(k)

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein

K-Number: K170779 · 2017-05-24

ApplicantTerang Nusa Sdn Bhd
Decision Date2017-05-24
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein is a medical device manufactured by Terang Nusa Sdn Bhd. It received FDA 510(k) clearance on 2017-05-24 under approval number K170779. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein?

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein is a medical device that received FDA 510(k) clearance on 2017-05-24. It is manufactured by Terang Nusa Sdn Bhd. The 510(k) number is K170779.

When was Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein approved by the FDA?

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein received FDA 510(k) clearance on 2017-05-24, under approval number K170779.

What company makes Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein?

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein is manufactured by Terang Nusa Sdn Bhd.

What is the FDA product code for Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein?

The FDA product code for Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein is LYY.

Related Clinical Trials

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Other Devices by Terang Nusa Sdn Bhd

K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink K153510Powder Free Polychloroprene Examination Glove Green

Related Devices (Code: LYY)

K162175Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or lessVietglove Corporation K161006Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloveHartalega Sdn Bhd K153744A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)A1 Glove Sdn Bhd K152593LATEX EXAMINATION GLOVE POWDER FREECareplus (M) Sdn Bhd K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATEDVietglove Corporation K161833LATEX EXAMINATION GLOVE POWDER FREECareglove Global Sdn. Bhd.

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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