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FDA 510(k)

Palm Care Blue Nitrile Examination Gloves Powder Free

K-Number: K202384 · 2020-12-02

Decision Date2020-12-02
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Palm Care Blue Nitrile Examination Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Care Thai Gloves Co. , Ltd.. It received FDA 510(k) clearance on 2020-12-02 under 510(k) number K202384. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Palm Care Blue Nitrile Examination Gloves Powder Free?

Palm Care Blue Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2020-12-02. The listed applicant is Hi-Care Thai Gloves Co. , Ltd.. The 510(k) number is K202384.

When did Palm Care Blue Nitrile Examination Gloves Powder Free receive FDA 510(k) clearance?

Palm Care Blue Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2020-12-02, under 510(k) number K202384.

Who is the listed applicant for Palm Care Blue Nitrile Examination Gloves Powder Free?

The FDA 510(k) record lists Hi-Care Thai Gloves Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Palm Care Blue Nitrile Examination Gloves Powder Free?

The FDA product code for Palm Care Blue Nitrile Examination Gloves Powder Free is LZA.

Other records listing Hi-Care Thai Gloves 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: LZA)

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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