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 GLOVE

K-Number: K163267 · 2017-03-24

ApplicantBrightway Holdings Sdn. Bhd.
Decision Date2017-03-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NITRILE EXAMINATION GLOVE is a medical device manufactured by Brightway Holdings Sdn. Bhd.. It received FDA 510(k) clearance on 2017-03-24 under approval number K163267. 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 GLOVE?

NITRILE EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Brightway Holdings Sdn. Bhd.. The 510(k) number is K163267.

When was NITRILE EXAMINATION GLOVE approved by the FDA?

NITRILE EXAMINATION GLOVE received FDA 510(k) clearance on 2017-03-24, under approval number K163267.

What company makes NITRILE EXAMINATION GLOVE?

NITRILE EXAMINATION GLOVE is manufactured by Brightway Holdings Sdn. Bhd..

What is the FDA product code for NITRILE EXAMINATION GLOVE?

The FDA product code for NITRILE EXAMINATION GLOVE is LZA.

Other Devices by Brightway Holdings Sdn. Bhd.

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs K170686Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs K162294BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM K162146Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) K211816Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

View all 7 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.

↑