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FDA 510(k)

PATIENT EXAMINATION GLOVES (LATEX)

K-Number: K891421 · 1989-06-06

ApplicantCharone, Inc.
Decision Date1989-06-06
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT EXAMINATION GLOVES (LATEX) is the device name listed in this FDA 510(k) record. The listed applicant is Charone, Inc.. It received FDA 510(k) clearance on 1989-06-06 under 510(k) number K891421. 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 PATIENT EXAMINATION GLOVES (LATEX)?

PATIENT EXAMINATION GLOVES (LATEX) is a medical device that received FDA 510(k) clearance on 1989-06-06. The listed applicant is Charone, Inc.. The 510(k) number is K891421.

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

PATIENT EXAMINATION GLOVES (LATEX) received FDA 510(k) clearance on 1989-06-06, under 510(k) number K891421.

Who is the listed applicant for PATIENT EXAMINATION GLOVES (LATEX)?

The FDA 510(k) record lists Charone, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATIENT EXAMINATION GLOVES (LATEX)?

The FDA product code for PATIENT EXAMINATION GLOVES (LATEX) is LYY.

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Related Devices (Code: LYY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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