FDA 510(k)

GLOVES, PATIENT EXAMINATION

K-Number: K890344 · 1989-04-26

Decision Date1989-04-26

Product CodeJTN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

GLOVES, PATIENT EXAMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Tomarc (M) Sdn Bhd. It received FDA 510(k) clearance on 1989-04-26 under 510(k) number K890344. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOVES, PATIENT EXAMINATION?

GLOVES, PATIENT EXAMINATION is a medical device that received FDA 510(k) clearance on 1989-04-26. The listed applicant is Tomarc (M) Sdn Bhd. The 510(k) number is K890344.

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

GLOVES, PATIENT EXAMINATION received FDA 510(k) clearance on 1989-04-26, under 510(k) number K890344.

Who is the listed applicant for GLOVES, PATIENT EXAMINATION?

The FDA 510(k) record lists Tomarc (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOVES, PATIENT EXAMINATION?

The FDA product code for GLOVES, PATIENT EXAMINATION is JTN.

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Other records listing Tomarc (M) Sdn Bhd as applicant

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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.