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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 the device name listed in this FDA 510(k) record. The listed applicant is Terang Nusa Sdn Bhd. It received FDA 510(k) clearance on 2016-11-28 under 510(k) 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. The listed applicant is Terang Nusa Sdn Bhd. The 510(k) number is K161932.

When did Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink receive FDA 510(k) clearance?

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

Who is the listed applicant for Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink?

The FDA 510(k) record lists Terang Nusa Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Terang Nusa Sdn Bhd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable proteinK153510Powder Free Polychloroprene Examination Glove Green

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionSw Technologies, Inc.K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company LimitedK260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd.K260806Nitrile Disposable Examination GlovesVista Industries,, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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