FDA 510(k)

BOSTON BRAND HYPOALLERGENIC LATEX GLOVES

K-Number: K923385 · 1992-10-15

Decision Date1992-10-15

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BOSTON BRAND HYPOALLERGENIC LATEX GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Boston Medical Corp.. It received FDA 510(k) clearance on 1992-10-15 under 510(k) number K923385. 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 BOSTON BRAND HYPOALLERGENIC LATEX GLOVES?

BOSTON BRAND HYPOALLERGENIC LATEX GLOVES is a medical device that received FDA 510(k) clearance on 1992-10-15. The listed applicant is Boston Medical Corp.. The 510(k) number is K923385.

When did BOSTON BRAND HYPOALLERGENIC LATEX GLOVES receive FDA 510(k) clearance?

BOSTON BRAND HYPOALLERGENIC LATEX GLOVES received FDA 510(k) clearance on 1992-10-15, under 510(k) number K923385.

Who is the listed applicant for BOSTON BRAND HYPOALLERGENIC LATEX GLOVES?

The FDA 510(k) record lists Boston Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSTON BRAND HYPOALLERGENIC LATEX GLOVES?

The FDA product code for BOSTON BRAND HYPOALLERGENIC LATEX GLOVES is LYY.

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Other records listing Boston Medical Corp. as applicant

K981947STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)K960841POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM K911146TAN CHONG GLOVE, HYPOALLERGENIC K910660BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC K904232BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC K891103STERILE PATIENT EXAMINATION GLOVE

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Related Devices (Code: LYY)

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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.