FDA 510(k)

POWDER FREE LATEX EXAMINATION GLOVES, BLACK

K-Number: K062709 · 2006-12-06

Decision Date2006-12-06

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER FREE LATEX EXAMINATION GLOVES, BLACK is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Maja Agung Latexindo. It received FDA 510(k) clearance on 2006-12-06 under 510(k) number K062709. 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 POWDER FREE LATEX EXAMINATION GLOVES, BLACK?

POWDER FREE LATEX EXAMINATION GLOVES, BLACK is a medical device that received FDA 510(k) clearance on 2006-12-06. The listed applicant is Pt. Maja Agung Latexindo. The 510(k) number is K062709.

When did POWDER FREE LATEX EXAMINATION GLOVES, BLACK receive FDA 510(k) clearance?

POWDER FREE LATEX EXAMINATION GLOVES, BLACK received FDA 510(k) clearance on 2006-12-06, under 510(k) number K062709.

Who is the listed applicant for POWDER FREE LATEX EXAMINATION GLOVES, BLACK?

The FDA 510(k) record lists Pt. Maja Agung Latexindo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE LATEX EXAMINATION GLOVES, BLACK?

The FDA product code for POWDER FREE LATEX EXAMINATION GLOVES, BLACK is LYY.

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Other records listing Pt. Maja Agung Latexindo as applicant

K212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)K161099Powder Free Nitrile Examination Gloves, Black K081488POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE K020040LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM K013996LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE K001274LATEX SURGEON SURGEON'S GLOVES POWDER-FREE 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.