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FDA 510(k)

GLOVE N GEL

K-Number: K896306 · 1989-12-11

ApplicantEms Medical, Inc.
Decision Date1989-12-11
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLOVE N GEL is the device name listed in this FDA 510(k) record. The listed applicant is Ems Medical, Inc.. It received FDA 510(k) clearance on 1989-12-11 under 510(k) number K896306. 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 GLOVE N GEL?

GLOVE N GEL is a medical device that received FDA 510(k) clearance on 1989-12-11. The listed applicant is Ems Medical, Inc.. The 510(k) number is K896306.

When did GLOVE N GEL receive FDA 510(k) clearance?

GLOVE N GEL received FDA 510(k) clearance on 1989-12-11, under 510(k) number K896306.

Who is the listed applicant for GLOVE N GEL?

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

What is the FDA product code for GLOVE N GEL?

The FDA product code for GLOVE N GEL is LYY.

Related Clinical Trials

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Other records listing Ems Medical, 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.

K890142A10 ULTRASCOPE RECORDER

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Official Source

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