FDA 510(k)

REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)

K-Number: K991677 · 2000-04-12

ApplicantLondon International Group, Inc.

Decision Date2000-04-12

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) is the device name listed in this FDA 510(k) record. The listed applicant is London International Group, Inc.. It received FDA 510(k) clearance on 2000-04-12 under 510(k) number K991677. 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 REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)?

REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) is a medical device that received FDA 510(k) clearance on 2000-04-12. The listed applicant is London International Group, Inc.. The 510(k) number is K991677.

When did REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) receive FDA 510(k) clearance?

REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) received FDA 510(k) clearance on 2000-04-12, under 510(k) number K991677.

Who is the listed applicant for REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)?

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

What is the FDA product code for REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)?

The FDA product code for REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) is LYY.

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Other records listing London International Group, Inc. as applicant

K984249SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE K980942REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE K980516REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE K971514REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE

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.