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FDA 510(k)

GUARDIAN II GLOVE

K-Number: K945577 · 1994-12-29

ApplicantGuardian Group, Inc.
Decision Date1994-12-29
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GUARDIAN II GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Guardian Group, Inc.. It received FDA 510(k) clearance on 1994-12-29 under 510(k) number K945577. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUARDIAN II GLOVE?

GUARDIAN II GLOVE is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is Guardian Group, Inc.. The 510(k) number is K945577.

When did GUARDIAN II GLOVE receive FDA 510(k) clearance?

GUARDIAN II GLOVE received FDA 510(k) clearance on 1994-12-29, under 510(k) number K945577.

Who is the listed applicant for GUARDIAN II GLOVE?

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

What is the FDA product code for GUARDIAN II GLOVE?

The FDA product code for GUARDIAN II GLOVE is LZC.

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Other records listing Guardian Group, Inc. as applicant

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.

K942313GUARDIAN GLOVE

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Official Source

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