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FDA 510(k)

ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR

K-Number: K012714 · 2001-10-31

ApplicantKoon Seng Sdn Bhd
Decision Date2001-10-31
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR is the device name listed in this FDA 510(k) record. The listed applicant is Koon Seng Sdn Bhd. It received FDA 510(k) clearance on 2001-10-31 under 510(k) number K012714. 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 ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR?

ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR is a medical device that received FDA 510(k) clearance on 2001-10-31. The listed applicant is Koon Seng Sdn Bhd. The 510(k) number is K012714.

When did ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR receive FDA 510(k) clearance?

ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR received FDA 510(k) clearance on 2001-10-31, under 510(k) number K012714.

Who is the listed applicant for ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR?

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

What is the FDA product code for ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR?

The FDA product code for ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR is LYY.

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Other records listing Koon Seng Sdn Bhd as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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