FDA 510(k)

SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES

K-Number: K011717 · 2001-08-14

ApplicantSunmax Enterprise Shanghai Co. , Ltd.

Decision Date2001-08-14

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Sunmax Enterprise Shanghai Co. , Ltd.. It received FDA 510(k) clearance on 2001-08-14 under 510(k) number K011717. 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 SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES?

SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2001-08-14. The listed applicant is Sunmax Enterprise Shanghai Co. , Ltd.. The 510(k) number is K011717.

When did SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES receive FDA 510(k) clearance?

SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES received FDA 510(k) clearance on 2001-08-14, under 510(k) number K011717.

Who is the listed applicant for SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES?

The FDA 510(k) record lists Sunmax Enterprise Shanghai Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES?

The FDA product code for SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES is LZA.

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Other records listing Sunmax Enterprise Shanghai Co. , Ltd. as applicant

K090336SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS K011765SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE K964964POWDER-FREE VINYL PATIENT EXAMINATION GLOVES K960746SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES

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.