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FDA 510(k)

LATEX PATIENT EXAMINATION GLOVES, HYPOALLERGENIC

K-Number: K912083 · 1991-06-27

ApplicantSterigard, Inc.
Decision Date1991-06-27
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX PATIENT EXAMINATION GLOVES, HYPOALLERGENIC is the device name listed in this FDA 510(k) record. The listed applicant is Sterigard, Inc.. It received FDA 510(k) clearance on 1991-06-27 under 510(k) number K912083. 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 PATIENT EXAMINATION GLOVES, HYPOALLERGENIC?

LATEX PATIENT EXAMINATION GLOVES, HYPOALLERGENIC is a medical device that received FDA 510(k) clearance on 1991-06-27. The listed applicant is Sterigard, Inc.. The 510(k) number is K912083.

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

LATEX PATIENT EXAMINATION GLOVES, HYPOALLERGENIC received FDA 510(k) clearance on 1991-06-27, under 510(k) number K912083.

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

The FDA 510(k) record lists Sterigard, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: LYY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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