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FDA 510(k)

TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)

K-Number: K021855 · 2002-08-05

ApplicantTop Glove Sdn. Bhd.
Decision Date2002-08-05
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is Top Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2002-08-05 under 510(k) number K021855. 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 TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)?

TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) is a medical device that received FDA 510(k) clearance on 2002-08-05. The listed applicant is Top Glove Sdn. Bhd.. The 510(k) number is K021855.

When did TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) receive FDA 510(k) clearance?

TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) received FDA 510(k) clearance on 2002-08-05, under 510(k) number K021855.

Who is the listed applicant for TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)?

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

What is the FDA product code for TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)?

The FDA product code for TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 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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