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FDA 510(k)

PREPOWDERED LATEX EXAMINATION GLOVE

K-Number: K970313 · 1997-03-11

ApplicantBesglove Healthcare Sdn. Bhd.
Decision Date1997-03-11
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PREPOWDERED LATEX EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Besglove Healthcare Sdn. Bhd.. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K970313. 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 PREPOWDERED LATEX EXAMINATION GLOVE?

PREPOWDERED LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1997-03-11. The listed applicant is Besglove Healthcare Sdn. Bhd.. The 510(k) number is K970313.

When did PREPOWDERED LATEX EXAMINATION GLOVE receive FDA 510(k) clearance?

PREPOWDERED LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 1997-03-11, under 510(k) number K970313.

Who is the listed applicant for PREPOWDERED LATEX EXAMINATION GLOVE?

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

What is the FDA product code for PREPOWDERED LATEX EXAMINATION GLOVE?

The FDA product code for PREPOWDERED LATEX EXAMINATION GLOVE 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

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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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