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FDA 510(k)

LATEX EXAMINATION GLOVE

K-Number: K904324 · 1990-10-03

ApplicantGallimore Ent., Inc.
Decision Date1990-10-03
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Gallimore Ent., Inc.. It received FDA 510(k) clearance on 1990-10-03 under 510(k) number K904324. 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?

LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1990-10-03. The listed applicant is Gallimore Ent., Inc.. The 510(k) number is K904324.

When did LATEX EXAMINATION GLOVE receive FDA 510(k) clearance?

LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 1990-10-03, under 510(k) number K904324.

Who is the listed applicant for LATEX EXAMINATION GLOVE?

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

What is the FDA product code for LATEX EXAMINATION GLOVE?

The FDA product code for LATEX EXAMINATION GLOVE is LYY.

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Official Source

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