Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Nitrile Examination Gloves (Blue, Violet Blue, White)

K-Number: K202402 · 2021-03-01

ApplicantJiangsu Tianshuo Medical Products Co., Ltd.
Decision Date2021-03-01
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Examination Gloves (Blue, Violet Blue, White) is a medical device manufactured by Jiangsu Tianshuo Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-03-01 under approval number K202402. 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 Examination Gloves (Blue, Violet Blue, White)?

Nitrile Examination Gloves (Blue, Violet Blue, White) is a medical device that received FDA 510(k) clearance on 2021-03-01. It is manufactured by Jiangsu Tianshuo Medical Products Co., Ltd.. The 510(k) number is K202402.

When was Nitrile Examination Gloves (Blue, Violet Blue, White) approved by the FDA?

Nitrile Examination Gloves (Blue, Violet Blue, White) received FDA 510(k) clearance on 2021-03-01, under approval number K202402.

What company makes Nitrile Examination Gloves (Blue, Violet Blue, White)?

Nitrile Examination Gloves (Blue, Violet Blue, White) is manufactured by Jiangsu Tianshuo Medical Products Co., Ltd..

What is the FDA product code for Nitrile Examination Gloves (Blue, Violet Blue, White)?

The FDA product code for Nitrile Examination Gloves (Blue, Violet Blue, White) is LZA.

Related Clinical Trials

NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) 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.

↑