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FDA 510(k)

Nitrile Glove Powder Free Black

K-Number: K182528 · 2018-11-15

ApplicantHaining Medical Products Co., Ltd.
Decision Date2018-11-15
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Glove Powder Free Black is the device name listed in this FDA 510(k) record. The listed applicant is Haining Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2018-11-15 under 510(k) number K182528. 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 Nitrile Glove Powder Free Black?

Nitrile Glove Powder Free Black is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Haining Medical Products Co., Ltd.. The 510(k) number is K182528.

When did Nitrile Glove Powder Free Black receive FDA 510(k) clearance?

Nitrile Glove Powder Free Black received FDA 510(k) clearance on 2018-11-15, under 510(k) number K182528.

Who is the listed applicant for Nitrile Glove Powder Free Black?

The FDA 510(k) record lists Haining Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Glove Powder Free Black?

The FDA product code for Nitrile Glove Powder Free Black is LZA.

Other records listing Haining Medical Products Co., Ltd. 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.

K183068Nitrile Glove Powder Free WhiteK152715HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR

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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