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FDA 510(k)

TOPLAS VINYL PATIENT EXAMINATION GLOVE

K-Number: K891646 · 1989-04-25

ApplicantToplas Industrial Co., Ltd.
Decision Date1989-04-25
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TOPLAS VINYL PATIENT EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Toplas Industrial Co., Ltd.. It received FDA 510(k) clearance on 1989-04-25 under 510(k) number K891646. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOPLAS VINYL PATIENT EXAMINATION GLOVE?

TOPLAS VINYL PATIENT EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1989-04-25. The listed applicant is Toplas Industrial Co., Ltd.. The 510(k) number is K891646.

When did TOPLAS VINYL PATIENT EXAMINATION GLOVE receive FDA 510(k) clearance?

TOPLAS VINYL PATIENT EXAMINATION GLOVE received FDA 510(k) clearance on 1989-04-25, under 510(k) number K891646.

Who is the listed applicant for TOPLAS VINYL PATIENT EXAMINATION GLOVE?

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

What is the FDA product code for TOPLAS VINYL PATIENT EXAMINATION GLOVE?

The FDA product code for TOPLAS VINYL PATIENT EXAMINATION GLOVE is LYZ.

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Related Devices (Code: LYZ)

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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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