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FDA 510(k)

VINYL EXAMINATION GLOVE, POWDER-FREE

K-Number: K944510 · 1994-10-18

ApplicantAmerican Gemini, Inc.
Decision Date1994-10-18
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VINYL EXAMINATION GLOVE, POWDER-FREE is the device name listed in this FDA 510(k) record. The listed applicant is American Gemini, Inc.. It received FDA 510(k) clearance on 1994-10-18 under 510(k) number K944510. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VINYL EXAMINATION GLOVE, POWDER-FREE?

VINYL EXAMINATION GLOVE, POWDER-FREE is a medical device that received FDA 510(k) clearance on 1994-10-18. The listed applicant is American Gemini, Inc.. The 510(k) number is K944510.

When did VINYL EXAMINATION GLOVE, POWDER-FREE receive FDA 510(k) clearance?

VINYL EXAMINATION GLOVE, POWDER-FREE received FDA 510(k) clearance on 1994-10-18, under 510(k) number K944510.

Who is the listed applicant for VINYL EXAMINATION GLOVE, POWDER-FREE?

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

What is the FDA product code for VINYL EXAMINATION GLOVE, POWDER-FREE?

The FDA product code for VINYL EXAMINATION GLOVE, POWDER-FREE is LYZ.

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Related Devices (Code: LYZ)

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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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