FDA 510(k)

POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES

K-Number: K013998 · 2002-02-13

Decision Date2002-02-13

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Sheen More Ent. Co., Ltd.. It received FDA 510(k) clearance on 2002-02-13 under 510(k) number K013998. 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 POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES?

POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES is a medical device that received FDA 510(k) clearance on 2002-02-13. The listed applicant is Sheen More Ent. Co., Ltd.. The 510(k) number is K013998.

When did POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES receive FDA 510(k) clearance?

POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES received FDA 510(k) clearance on 2002-02-13, under 510(k) number K013998.

Who is the listed applicant for POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES?

The FDA 510(k) record lists Sheen More Ent. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES?

The FDA product code for POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES is LZA.

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Other records listing Sheen More Ent. Co., Ltd. as applicant

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Related Devices (Code: LZA)

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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.