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FDA 510(k)

Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs

K-Number: K181130 · 2018-08-10

ApplicantHebei Titans Hongsen Medical Technology Co., Ltd.
Decision Date2018-08-10
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a medical device manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-08-10 under approval number K181130. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs?

Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-08-10. It is manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K181130.

When was Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs approved by the FDA?

Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-08-10, under approval number K181130.

What company makes Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs?

Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd..

What is the FDA product code for Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs?

The FDA product code for Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is LZC.

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

Other Devices by Hebei Titans Hongsen Medical Technology Co., Ltd.

K182043Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) K212097Disposable medical surgical mask K211229Vinyl compound examination gloves K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) K223895Disposable Medical Nitrile Examination Gloves K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)

View all 7 devices →

Related Devices (Code: LZC)

K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health K151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsMaxter Glove Manufacturing Sdn Bhd K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy DrugsGmp Medicare Sdn Bhd (F25) K172642Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTCareplus (M) 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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