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FDA 510(k)

WARDEN LATEX EXAMINATION GLOVES

K-Number: K893179 · 1989-06-19

ApplicantKuo Jun Ent. Co., Ltd.
Decision Date1989-06-19
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WARDEN LATEX EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Kuo Jun Ent. Co., Ltd.. It received FDA 510(k) clearance on 1989-06-19 under 510(k) number K893179. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WARDEN LATEX EXAMINATION GLOVES?

WARDEN LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1989-06-19. The listed applicant is Kuo Jun Ent. Co., Ltd.. The 510(k) number is K893179.

When did WARDEN LATEX EXAMINATION GLOVES receive FDA 510(k) clearance?

WARDEN LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 1989-06-19, under 510(k) number K893179.

Who is the listed applicant for WARDEN LATEX EXAMINATION GLOVES?

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

What is the FDA product code for WARDEN LATEX EXAMINATION GLOVES?

The FDA product code for WARDEN LATEX EXAMINATION GLOVES is LYY.

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Related Devices (Code: LYY)

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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.

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