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FDA 510(k)

Vinyl Co-Polymer Powder-free Examination Gloves, Black

K-Number: K220240 · 2022-03-31

Decision Date2022-03-31
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vinyl Co-Polymer Powder-free Examination Gloves, Black is the device name listed in this FDA 510(k) record. The listed applicant is Grand Work Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2022-03-31 under 510(k) number K220240. 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 Co-Polymer Powder-free Examination Gloves, Black?

Vinyl Co-Polymer Powder-free Examination Gloves, Black is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is Grand Work Plastic Products Co., Ltd.. The 510(k) number is K220240.

When did Vinyl Co-Polymer Powder-free Examination Gloves, Black receive FDA 510(k) clearance?

Vinyl Co-Polymer Powder-free Examination Gloves, Black received FDA 510(k) clearance on 2022-03-31, under 510(k) number K220240.

Who is the listed applicant for Vinyl Co-Polymer Powder-free Examination Gloves, Black?

The FDA 510(k) record lists Grand Work Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vinyl Co-Polymer Powder-free Examination Gloves, Black?

The FDA product code for Vinyl Co-Polymer Powder-free Examination Gloves, Black is LYZ.

Other records listing Grand Work Plastic 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.

View all 8 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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