FDA 510(k)

POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)

K-Number: K012786 · 2001-10-01

Decision Date2001-10-01

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) is the device name listed in this FDA 510(k) record. The listed applicant is Shamrock Manufacturing Company. It received FDA 510(k) clearance on 2001-10-01 under 510(k) number K012786. 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 POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)?

POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) is a medical device that received FDA 510(k) clearance on 2001-10-01. The listed applicant is Shamrock Manufacturing Company. The 510(k) number is K012786.

When did POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) receive FDA 510(k) clearance?

POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) received FDA 510(k) clearance on 2001-10-01, under 510(k) number K012786.

Who is the listed applicant for POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)?

The FDA 510(k) record lists Shamrock Manufacturing Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)?

The FDA product code for POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) is LZA.

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Other records listing Shamrock Manufacturing Company as applicant

K030386POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE

Related Devices (Code: LZA)

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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.