FDA 510(k)

PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC

K-Number: K915251 · 1993-01-22

Decision Date1993-01-22

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC is the device name listed in this FDA 510(k) record. The listed applicant is Supermax Sdn Bhd. It received FDA 510(k) clearance on 1993-01-22 under 510(k) number K915251. 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 PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC?

PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC is a medical device that received FDA 510(k) clearance on 1993-01-22. The listed applicant is Supermax Sdn Bhd. The 510(k) number is K915251.

When did PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC receive FDA 510(k) clearance?

PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC received FDA 510(k) clearance on 1993-01-22, under 510(k) number K915251.

Who is the listed applicant for PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC?

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

What is the FDA product code for PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC?

The FDA product code for PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC is LYY.

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Other records listing Supermax Sdn Bhd 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.