FDA 510(k)

POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM

K-Number: K030325 · 2003-03-28

ApplicantPt.Shamrock Manufacturing Corp.

Decision Date2003-03-28

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM 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 2003-03-28 under 510(k) number K030325. 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 POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM?

POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM is a medical device that received FDA 510(k) clearance on 2003-03-28. The listed applicant is Pt.Shamrock Manufacturing Corp.. The 510(k) number is K030325.

When did POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM receive FDA 510(k) clearance?

POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM received FDA 510(k) clearance on 2003-03-28, under 510(k) number K030325.

Who is the listed applicant for POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM?

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 POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM?

The FDA product code for POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM 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 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)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

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.