FDA 510(k)

LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS)

K-Number: K991686 · 1999-06-11

ApplicantArista Latindo Industrial Ltd. P.T

Decision Date1999-06-11

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is Arista Latindo Industrial Ltd. P.T. It received FDA 510(k) clearance on 1999-06-11 under 510(k) number K991686. 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 LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS)?

LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) is a medical device that received FDA 510(k) clearance on 1999-06-11. The listed applicant is Arista Latindo Industrial Ltd. P.T. The 510(k) number is K991686.

When did LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) receive FDA 510(k) clearance?

LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) received FDA 510(k) clearance on 1999-06-11, under 510(k) number K991686.

Who is the listed applicant for LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS)?

The FDA 510(k) record lists Arista Latindo Industrial Ltd. P.T as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS)?

The FDA product code for LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) is LYY.

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Other records listing Arista Latindo Industrial Ltd. P.T as applicant

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Related Devices (Code: LYY)

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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.