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FDA 510(k)

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS

K-Number: K993760 · 2000-05-15

ApplicantHartalega Sdn Bhd
Decision Date2000-05-15
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega Sdn Bhd. It received FDA 510(k) clearance on 2000-05-15 under 510(k) number K993760. 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 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS?

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS is a medical device that received FDA 510(k) clearance on 2000-05-15. The listed applicant is Hartalega Sdn Bhd. The 510(k) number is K993760.

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

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS received FDA 510(k) clearance on 2000-05-15, under 510(k) number K993760.

Who is the listed applicant for POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS?

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

What is the FDA product code for POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS?

The FDA product code for POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS is LYY.

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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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