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FDA 510(k)

DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES

K-Number: K925358 · 1993-04-12

ApplicantColonial Surgical Supply, Inc.
Decision Date1993-04-12
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Colonial Surgical Supply, Inc.. It received FDA 510(k) clearance on 1993-04-12 under 510(k) number K925358. 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 DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES?

DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1993-04-12. The listed applicant is Colonial Surgical Supply, Inc.. The 510(k) number is K925358.

When did DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES receive FDA 510(k) clearance?

DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES received FDA 510(k) clearance on 1993-04-12, under 510(k) number K925358.

Who is the listed applicant for DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES?

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

What is the FDA product code for DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES?

The FDA product code for DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES is LYY.

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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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