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FDA 510(k)

LANGS EXAM GLOVE

K-Number: K890776 · 1989-05-12

ApplicantLangs Intl., Inc.
Decision Date1989-05-12
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LANGS EXAM GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Langs Intl., Inc.. It received FDA 510(k) clearance on 1989-05-12 under 510(k) number K890776. 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 LANGS EXAM GLOVE?

LANGS EXAM GLOVE is a medical device that received FDA 510(k) clearance on 1989-05-12. The listed applicant is Langs Intl., Inc.. The 510(k) number is K890776.

When did LANGS EXAM GLOVE receive FDA 510(k) clearance?

LANGS EXAM GLOVE received FDA 510(k) clearance on 1989-05-12, under 510(k) number K890776.

Who is the listed applicant for LANGS EXAM GLOVE?

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

What is the FDA product code for LANGS EXAM GLOVE?

The FDA product code for LANGS EXAM GLOVE is LYY.

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Official Source

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