FDA 510(k)

COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC)

K-Number: K951137 · 1995-04-13

ApplicantWembley Rubber Products (M) Sdn Bhd

Decision Date1995-04-13

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) is the device name listed in this FDA 510(k) record. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. It received FDA 510(k) clearance on 1995-04-13 under 510(k) number K951137. 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 COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC)?

COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) is a medical device that received FDA 510(k) clearance on 1995-04-13. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. The 510(k) number is K951137.

When did COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) receive FDA 510(k) clearance?

COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) received FDA 510(k) clearance on 1995-04-13, under 510(k) number K951137.

Who is the listed applicant for COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC)?

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

What is the FDA product code for COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC)?

The FDA product code for COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) is LYY.

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Other records listing Wembley Rubber Products (M) Sdn Bhd as applicant

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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.