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FDA 510(k)

NBR Synthetic Nitrile Examination Gloves

K-Number: K212436 · 2021-12-23

ApplicantShandong Langtai International Trade Co., Ltd.
Decision Date2021-12-23
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NBR Synthetic Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Langtai International Trade Co., Ltd.. It received FDA 510(k) clearance on 2021-12-23 under 510(k) number K212436. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NBR Synthetic Nitrile Examination Gloves?

NBR Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-23. The listed applicant is Shandong Langtai International Trade Co., Ltd.. The 510(k) number is K212436.

When did NBR Synthetic Nitrile Examination Gloves receive FDA 510(k) clearance?

NBR Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2021-12-23, under 510(k) number K212436.

Who is the listed applicant for NBR Synthetic Nitrile Examination Gloves?

The FDA 510(k) record lists Shandong Langtai International Trade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NBR Synthetic Nitrile Examination Gloves?

The FDA product code for NBR Synthetic Nitrile Examination Gloves is LYZ.

Related Devices (Code: LYZ)

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.

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

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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