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FDA 510(k)

Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)

K-Number: K163168 · 2017-02-23

ApplicantHebei Hongtai Plastic Products Company Limited
Decision Date2017-02-23
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) is a medical device manufactured by Hebei Hongtai Plastic Products Company Limited. It received FDA 510(k) clearance on 2017-02-23 under approval number K163168. 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 Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)?

Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by Hebei Hongtai Plastic Products Company Limited. The 510(k) number is K163168.

When was Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) approved by the FDA?

Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) received FDA 510(k) clearance on 2017-02-23, under approval number K163168.

What company makes Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)?

Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) is manufactured by Hebei Hongtai Plastic Products Company Limited.

What is the FDA product code for Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)?

The FDA product code for Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) is LYZ.

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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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