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)

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color

K-Number: K162312 · 2017-07-25

ApplicantShen Wei USA, Inc.
Decision Date2017-07-25
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is a medical device manufactured by Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2017-07-25 under approval number K162312. 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 Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color?

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is a medical device that received FDA 510(k) clearance on 2017-07-25. It is manufactured by Shen Wei USA, Inc.. The 510(k) number is K162312.

When was Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color approved by the FDA?

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color received FDA 510(k) clearance on 2017-07-25, under approval number K162312.

What company makes Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color?

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is manufactured by Shen Wei USA, Inc..

What is the FDA product code for Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color?

The FDA product code for Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is LZA.

Other Devices by Shen Wei USA, Inc.

K172678THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE K170290Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr K173766PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs K190466PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate K213144Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors K211620Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)

View all 18 devices →

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.

↑