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FDA 510(k)

ELASTYREN - EXAMINATION AND DENTAL GLOVES

K-Number: K901394 · 1990-08-10

ApplicantDanpren Gloves A/S
Decision Date1990-08-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELASTYREN - EXAMINATION AND DENTAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Danpren Gloves A/S. It received FDA 510(k) clearance on 1990-08-10 under 510(k) number K901394. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELASTYREN - EXAMINATION AND DENTAL GLOVES?

ELASTYREN - EXAMINATION AND DENTAL GLOVES is a medical device that received FDA 510(k) clearance on 1990-08-10. The listed applicant is Danpren Gloves A/S. The 510(k) number is K901394.

When did ELASTYREN - EXAMINATION AND DENTAL GLOVES receive FDA 510(k) clearance?

ELASTYREN - EXAMINATION AND DENTAL GLOVES received FDA 510(k) clearance on 1990-08-10, under 510(k) number K901394.

Who is the listed applicant for ELASTYREN - EXAMINATION AND DENTAL GLOVES?

The FDA 510(k) record lists Danpren Gloves A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELASTYREN - EXAMINATION AND DENTAL GLOVES?

The FDA product code for ELASTYREN - EXAMINATION AND DENTAL GLOVES is LZA.

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Related Devices (Code: LZA)

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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