FDA 510(k)

FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE

K-Number: K051987 · 2005-10-06

Decision Date2005-10-06

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Mandiri Inti Buana. It received FDA 510(k) clearance on 2005-10-06 under 510(k) number K051987. 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 FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE?

FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE is a medical device that received FDA 510(k) clearance on 2005-10-06. The listed applicant is Pt. Mandiri Inti Buana. The 510(k) number is K051987.

When did FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE receive FDA 510(k) clearance?

FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE received FDA 510(k) clearance on 2005-10-06, under 510(k) number K051987.

Who is the listed applicant for FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE?

The FDA 510(k) record lists Pt. Mandiri Inti Buana as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE?

The FDA product code for FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE is LYY.

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Other records listing Pt. Mandiri Inti Buana as applicant

K042239FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE K031754FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE K031020FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

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.