FDA 510(k)

LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE

K-Number: K030134 · 2003-03-25

ApplicantPt.Shamrock Manufacturing Corp.

Decision Date2003-03-25

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE 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 2003-03-25 under 510(k) number K030134. 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 LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE?

LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE is a medical device that received FDA 510(k) clearance on 2003-03-25. The listed applicant is Pt.Shamrock Manufacturing Corp.. The 510(k) number is K030134.

When did LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE receive FDA 510(k) clearance?

LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE received FDA 510(k) clearance on 2003-03-25, under 510(k) number K030134.

Who is the listed applicant for LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE?

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 LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE?

The FDA product code for LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE is LYY.

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Other records listing Pt.Shamrock Manufacturing Corp. as applicant

K081040POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE K052709POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE K052382POWDER FREE NITRILE EXAMINATION GLOVES, BLUE K030325POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM 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.