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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 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 2016-03-21 under 510(k) 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. The listed applicant is Terang Nusa Sdn Bhd. The 510(k) number is K153510.

When did Powder Free Polychloroprene Examination Glove Green receive FDA 510(k) clearance?

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

Who is the listed applicant for Powder Free Polychloroprene Examination Glove Green?

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 Green?

The FDA product code for Powder Free Polychloroprene Examination Glove Green 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 proteinK161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink

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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