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FDA 510(k)

EMAS GLOVE

K-Number: K893724 · 1989-08-10

ApplicantExim Mfg. & Assoc. Services, Sdn Bhd
Decision Date1989-08-10
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EMAS GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Exim Mfg. & Assoc. Services, Sdn Bhd. It received FDA 510(k) clearance on 1989-08-10 under 510(k) number K893724. 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 EMAS GLOVE?

EMAS GLOVE is a medical device that received FDA 510(k) clearance on 1989-08-10. The listed applicant is Exim Mfg. & Assoc. Services, Sdn Bhd. The 510(k) number is K893724.

When did EMAS GLOVE receive FDA 510(k) clearance?

EMAS GLOVE received FDA 510(k) clearance on 1989-08-10, under 510(k) number K893724.

Who is the listed applicant for EMAS GLOVE?

The FDA 510(k) record lists Exim Mfg. & Assoc. Services, Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMAS GLOVE?

The FDA product code for EMAS GLOVE is 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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