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FDA 510(k)

DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES

K-Number: K891819 · 1989-08-09

ApplicantAdler Industries, Inc.
Decision Date1989-08-09
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Adler Industries, Inc.. It received FDA 510(k) clearance on 1989-08-09 under 510(k) number K891819. 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 DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES?

DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES is a medical device that received FDA 510(k) clearance on 1989-08-09. The listed applicant is Adler Industries, Inc.. The 510(k) number is K891819.

When did DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES receive FDA 510(k) clearance?

DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES received FDA 510(k) clearance on 1989-08-09, under 510(k) number K891819.

Who is the listed applicant for DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES?

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

What is the FDA product code for DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES?

The FDA product code for DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES is LYY.

Related Clinical Trials

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.

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Related Devices (Code: LYY)

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.

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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.

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