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FDA 510(k)

DASH MEDICAL GLOVES

K-Number: K912038 · 1991-06-03

ApplicantSafehealth Labs
Decision Date1991-06-03
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DASH MEDICAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Safehealth Labs. It received FDA 510(k) clearance on 1991-06-03 under 510(k) number K912038. 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 DASH MEDICAL GLOVES?

DASH MEDICAL GLOVES is a medical device that received FDA 510(k) clearance on 1991-06-03. The listed applicant is Safehealth Labs. The 510(k) number is K912038.

When did DASH MEDICAL GLOVES receive FDA 510(k) clearance?

DASH MEDICAL GLOVES received FDA 510(k) clearance on 1991-06-03, under 510(k) number K912038.

Who is the listed applicant for DASH MEDICAL GLOVES?

The FDA 510(k) record lists Safehealth Labs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DASH MEDICAL GLOVES?

The FDA product code for DASH MEDICAL 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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