FDA 510(k)

BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE

K-Number: K062526 · 2007-04-13

Decision Date2007-04-13

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Multisafe Sdn. Bhd.. It received FDA 510(k) clearance on 2007-04-13 under 510(k) number K062526. 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 BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE?

BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE is a medical device that received FDA 510(k) clearance on 2007-04-13. The listed applicant is Multisafe Sdn. Bhd.. The 510(k) number is K062526.

When did BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE receive FDA 510(k) clearance?

BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE received FDA 510(k) clearance on 2007-04-13, under 510(k) number K062526.

Who is the listed applicant for BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE?

The FDA 510(k) record lists Multisafe Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE?

The FDA product code for BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE is LYY.

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Other records listing Multisafe Sdn. Bhd. as applicant

K161085Nitrile Patient Examination Powder Free Glove, Textured, Black K062527BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE K011293POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES K001497MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)K001619MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)K000999MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

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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.