FDA 510(k)

POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE

K-Number: K081040 · 2008-05-20

ApplicantPt.Shamrock Manufacturing Corp.

Decision Date2008-05-20

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE is the device name listed in this FDA 510(k) record. The listed applicant is Pt.Shamrock Manufacturing Corp.. It received FDA 510(k) clearance on 2008-05-20 under 510(k) number K081040. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE?

POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE is a medical device that received FDA 510(k) clearance on 2008-05-20. The listed applicant is Pt.Shamrock Manufacturing Corp.. The 510(k) number is K081040.

When did POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE receive FDA 510(k) clearance?

POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE received FDA 510(k) clearance on 2008-05-20, under 510(k) number K081040.

Who is the listed applicant for POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE?

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

What is the FDA product code for POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE?

The FDA product code for POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE is LYY.

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Other records listing Pt.Shamrock Manufacturing Corp. as applicant

K052709POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE K052382POWDER FREE NITRILE EXAMINATION GLOVES, BLUE K030325POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM K030134LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE K030560POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE K011712LATEX EXAMINATION GLOVES- POWDER FREE, BLUE

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Related Devices (Code: LYY)

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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.