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FDA 510(k)

MULTIPLE-VINYL EXAM GLOVE, POWDERED

K-Number: K003133 · 2000-11-07

ApplicantExcellence Ent. Co., Ltd.
Decision Date2000-11-07
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MULTIPLE-VINYL EXAM GLOVE, POWDERED is the device name listed in this FDA 510(k) record. The listed applicant is Excellence Ent. Co., Ltd.. It received FDA 510(k) clearance on 2000-11-07 under 510(k) number K003133. 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 MULTIPLE-VINYL EXAM GLOVE, POWDERED?

MULTIPLE-VINYL EXAM GLOVE, POWDERED is a medical device that received FDA 510(k) clearance on 2000-11-07. The listed applicant is Excellence Ent. Co., Ltd.. The 510(k) number is K003133.

When did MULTIPLE-VINYL EXAM GLOVE, POWDERED receive FDA 510(k) clearance?

MULTIPLE-VINYL EXAM GLOVE, POWDERED received FDA 510(k) clearance on 2000-11-07, under 510(k) number K003133.

Who is the listed applicant for MULTIPLE-VINYL EXAM GLOVE, POWDERED?

The FDA 510(k) record lists Excellence Ent. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIPLE-VINYL EXAM GLOVE, POWDERED?

The FDA product code for MULTIPLE-VINYL EXAM GLOVE, POWDERED is LYZ.

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Related Devices (Code: LYZ)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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