FDA 510(k)

ELASTYREN(R) PATIENT EXAMINATION GLOVES

K-Number: K946291 · 1995-02-14

Decision Date1995-02-14

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ELASTYREN(R) PATIENT EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Eci Medical Technologies, Inc.. It received FDA 510(k) clearance on 1995-02-14 under 510(k) number K946291. 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(R) PATIENT EXAMINATION GLOVES?

ELASTYREN(R) PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1995-02-14. The listed applicant is Eci Medical Technologies, Inc.. The 510(k) number is K946291.

When did ELASTYREN(R) PATIENT EXAMINATION GLOVES receive FDA 510(k) clearance?

ELASTYREN(R) PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 1995-02-14, under 510(k) number K946291.

Who is the listed applicant for ELASTYREN(R) PATIENT EXAMINATION GLOVES?

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

What is the FDA product code for ELASTYREN(R) PATIENT EXAMINATION GLOVES?

The FDA product code for ELASTYREN(R) PATIENT EXAMINATION GLOVES is LZA.

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Other records listing Eci Medical Technologies, Inc. as applicant

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Related Devices (Code: LZA)

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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.