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FDA 510(k)

POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE

K-Number: K062138 · 2006-10-05

ApplicantMolnlycke Health Care, Inc.
Decision Date2006-10-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care, Inc.. It received FDA 510(k) clearance on 2006-10-05 under 510(k) number K062138. 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 POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE?

POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2006-10-05. The listed applicant is Molnlycke Health Care, Inc.. The 510(k) number is K062138.

When did POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE receive FDA 510(k) clearance?

POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE received FDA 510(k) clearance on 2006-10-05, under 510(k) number K062138.

Who is the listed applicant for POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE?

The FDA 510(k) record lists Molnlycke Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE?

The FDA product code for POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE is LZA.

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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.

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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.

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