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FDA 510(k)

PRE-POWDERED VINYL EXAM GLOVES

K-Number: K041379 · 2004-08-31

Decision Date2004-08-31
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRE-POWDERED VINYL EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Shijiazhuang Wally Plastics Co., Ltd.. It received FDA 510(k) clearance on 2004-08-31 under 510(k) number K041379. 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 PRE-POWDERED VINYL EXAM GLOVES?

PRE-POWDERED VINYL EXAM GLOVES is a medical device that received FDA 510(k) clearance on 2004-08-31. The listed applicant is Shijiazhuang Wally Plastics Co., Ltd.. The 510(k) number is K041379.

When did PRE-POWDERED VINYL EXAM GLOVES receive FDA 510(k) clearance?

PRE-POWDERED VINYL EXAM GLOVES received FDA 510(k) clearance on 2004-08-31, under 510(k) number K041379.

Who is the listed applicant for PRE-POWDERED VINYL EXAM GLOVES?

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

What is the FDA product code for PRE-POWDERED VINYL EXAM GLOVES?

The FDA product code for PRE-POWDERED VINYL EXAM GLOVES 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 Shijiazhuang Wally Plastics 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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