FDA 510(k)

MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

K-Number: K982691 · 1998-10-09

ApplicantPerusahaan Intan Emas Sdn. Bhd.

Decision Date1998-10-09

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is Perusahaan Intan Emas Sdn. Bhd.. It received FDA 510(k) clearance on 1998-10-09 under 510(k) number K982691. 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 MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)?

MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) is a medical device that received FDA 510(k) clearance on 1998-10-09. The listed applicant is Perusahaan Intan Emas Sdn. Bhd.. The 510(k) number is K982691.

When did MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) receive FDA 510(k) clearance?

MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) received FDA 510(k) clearance on 1998-10-09, under 510(k) number K982691.

Who is the listed applicant for MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)?

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

What is the FDA product code for MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)?

The FDA product code for MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) is LYY.

Related Clinical Trials

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Other records listing Perusahaan Intan Emas Sdn. Bhd. as applicant

K935033MULTI-COMFORT POWDER FREE K925363HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES K892074PATIENT EXAMINATION GLOVES (LATEX)

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.