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FDA 510(k)

ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM

K-Number: K030331 · 2003-03-21

ApplicantPerusahaan Getah Asas Sdn. Bhd.
Decision Date2003-03-21
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. It received FDA 510(k) clearance on 2003-03-21 under 510(k) number K030331. 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 ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM?

ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM is a medical device that received FDA 510(k) clearance on 2003-03-21. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. The 510(k) number is K030331.

When did ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM receive FDA 510(k) clearance?

ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM received FDA 510(k) clearance on 2003-03-21, under 510(k) number K030331.

Who is the listed applicant for ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM?

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

What is the FDA product code for ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM?

The FDA product code for ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM is LYY.

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Other records listing Perusahaan Getah Asas 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

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

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