FDA 510(k)

BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE

K-Number: K992588 · 1999-09-10

ApplicantFormosa Glove Industrial Co., Ltd.

Decision Date1999-09-10

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE is the device name listed in this FDA 510(k) record. The listed applicant is Formosa Glove Industrial Co., Ltd.. It received FDA 510(k) clearance on 1999-09-10 under 510(k) number K992588. 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 BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE?

BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE is a medical device that received FDA 510(k) clearance on 1999-09-10. The listed applicant is Formosa Glove Industrial Co., Ltd.. The 510(k) number is K992588.

When did BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE receive FDA 510(k) clearance?

BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE received FDA 510(k) clearance on 1999-09-10, under 510(k) number K992588.

Who is the listed applicant for BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE?

The FDA 510(k) record lists Formosa Glove Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE?

The FDA product code for BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE is LZA.

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Other records listing Formosa Glove Industrial 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.