FDA 510(k)

LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING

K-Number: K990468 · 1999-04-27

Decision Date1999-04-27

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING is the device name listed in this FDA 510(k) record. The listed applicant is Top Glove Sdn. Bhd.. It received FDA 510(k) clearance on 1999-04-27 under 510(k) number K990468. 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 GLOVE W/ LOW PROTEIN LABELING?

LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING is a medical device that received FDA 510(k) clearance on 1999-04-27. The listed applicant is Top Glove Sdn. Bhd.. The 510(k) number is K990468.

When did LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING receive FDA 510(k) clearance?

LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING received FDA 510(k) clearance on 1999-04-27, under 510(k) number K990468.

Who is the listed applicant for LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING?

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

What is the FDA product code for LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING?

The FDA product code for LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING is LYY.

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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.