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)

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE

K-Number: K171093 · 2017-07-19

ApplicantSanrea Healthcare Products Pvt, Ltd.
Decision Date2017-07-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE is a medical device manufactured by Sanrea Healthcare Products Pvt, Ltd.. It received FDA 510(k) clearance on 2017-07-19 under approval number K171093. 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 STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE?

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE is a medical device that received FDA 510(k) clearance on 2017-07-19. It is manufactured by Sanrea Healthcare Products Pvt, Ltd.. The 510(k) number is K171093.

When was STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE approved by the FDA?

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE received FDA 510(k) clearance on 2017-07-19, under approval number K171093.

What company makes STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE?

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE is manufactured by Sanrea Healthcare Products Pvt, Ltd..

What is the FDA product code for STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE?

The FDA product code for STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE is LZA.

Related Clinical Trials

NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT07589452 Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction NOT_YET_RECRUITING NCT03404895 The Mount Sinai Diabetic Foot Ulcer Prospective Trial WITHDRAWN NCT07577232 Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess RECRUITING NCT05059041 Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome COMPLETED NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING

Other Devices by Sanrea Healthcare Products Pvt, Ltd.

K171550Sterile Latex Surgical Gloves, Powder Free K171367SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)

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.

↑