FDA 510(k)

POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL

K-Number: K130667 · 2013-07-24

Decision Date2013-07-24

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL is the device name listed in this FDA 510(k) record. The listed applicant is Preventive Care, Inc.. It received FDA 510(k) clearance on 2013-07-24 under 510(k) number K130667. 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 COATED WITH ALLOGEL?

POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL is a medical device that received FDA 510(k) clearance on 2013-07-24. The listed applicant is Preventive Care, Inc.. The 510(k) number is K130667.

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

POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL received FDA 510(k) clearance on 2013-07-24, under 510(k) number K130667.

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

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

What is the FDA product code for POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL?

The FDA product code for POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL is LYY.

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Other records listing Preventive Care, Inc. as applicant

K110102POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG K924233SAVACARE LATEX EXAMINATION GLOVES

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.