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FDA 510(k)

POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)

K-Number: K081657 · 2008-08-20

Decision Date2008-08-20
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Cureguard Glove Co., Ltd.. It received FDA 510(k) clearance on 2008-08-20 under 510(k) number K081657. 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 POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)?

POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) is a medical device that received FDA 510(k) clearance on 2008-08-20. The listed applicant is Jiangsu Cureguard Glove Co., Ltd.. The 510(k) number is K081657.

When did POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) receive FDA 510(k) clearance?

POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) received FDA 510(k) clearance on 2008-08-20, under 510(k) number K081657.

Who is the listed applicant for POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)?

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

What is the FDA product code for POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)?

The FDA product code for POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) 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 Jiangsu Cureguard Glove 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.

View all 11 devices →

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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