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FDA 510(k)

LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE)

K-Number: K946155 · 1995-01-17

ApplicantMala Intertrade Co., Ltd.
Decision Date1995-01-17
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE) is the device name listed in this FDA 510(k) record. The listed applicant is Mala Intertrade Co., Ltd.. It received FDA 510(k) clearance on 1995-01-17 under 510(k) number K946155. 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 LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE)?

LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE) is a medical device that received FDA 510(k) clearance on 1995-01-17. The listed applicant is Mala Intertrade Co., Ltd.. The 510(k) number is K946155.

When did LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE) receive FDA 510(k) clearance?

LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE) received FDA 510(k) clearance on 1995-01-17, under 510(k) number K946155.

Who is the listed applicant for LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE)?

The FDA 510(k) record lists Mala Intertrade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE)?

The FDA product code for LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE) 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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