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FDA 510(k)

POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO)

K-Number: K040532 · 2004-03-23

Decision Date2004-03-23
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) is the device name listed in this FDA 510(k) record. The listed applicant is Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd.. It received FDA 510(k) clearance on 2004-03-23 under 510(k) number K040532. 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 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO)?

POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) is a medical device that received FDA 510(k) clearance on 2004-03-23. The listed applicant is Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd.. The 510(k) number is K040532.

When did POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) receive FDA 510(k) clearance?

POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) received FDA 510(k) clearance on 2004-03-23, under 510(k) number K040532.

Who is the listed applicant for POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO)?

The FDA 510(k) record lists Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO)?

The FDA product code for POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) is LYZ.

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.

Other records listing Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd. as applicant

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.

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.

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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