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FDA 510(k)

HYGEIA EXAMINATION GLOVES

K-Number: K891805 · 1989-05-12

ApplicantHygeia , Ltd.
Decision Date1989-05-12
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYGEIA EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Hygeia , Ltd.. It received FDA 510(k) clearance on 1989-05-12 under 510(k) number K891805. 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 HYGEIA EXAMINATION GLOVES?

HYGEIA EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1989-05-12. The listed applicant is Hygeia , Ltd.. The 510(k) number is K891805.

When did HYGEIA EXAMINATION GLOVES receive FDA 510(k) clearance?

HYGEIA EXAMINATION GLOVES received FDA 510(k) clearance on 1989-05-12, under 510(k) number K891805.

Who is the listed applicant for HYGEIA EXAMINATION GLOVES?

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

What is the FDA product code for HYGEIA EXAMINATION GLOVES?

The FDA product code for HYGEIA EXAMINATION GLOVES is LYY.

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Official Source

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