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FDA 510(k)

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE

K-Number: K171093 · 2017-07-19

Decision Date2017-07-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE is the device name listed in this FDA 510(k) record. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. It received FDA 510(k) clearance on 2017-07-19 under 510(k) 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. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. The 510(k) number is K171093.

When did STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE receive FDA 510(k) clearance?

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

Who is the listed applicant for STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE?

The FDA 510(k) record lists Sanrea Healthcare Products Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Sanrea Healthcare Products Pvt, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.