FDA 510(k)

LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)

K-Number: K960842 · 1997-03-19

ApplicantCrocker Industrial Resources Sdn. Bhd.

Decision Date1997-03-19

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) is the device name listed in this FDA 510(k) record. The listed applicant is Crocker Industrial Resources Sdn. Bhd.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K960842. 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 EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)?

LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Crocker Industrial Resources Sdn. Bhd.. The 510(k) number is K960842.

When did LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) receive FDA 510(k) clearance?

LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) received FDA 510(k) clearance on 1997-03-19, under 510(k) number K960842.

Who is the listed applicant for LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)?

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

What is the FDA product code for LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)?

The FDA product code for LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) is LYY.

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Other records listing Crocker Industrial Resources Sdn. Bhd. as applicant

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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.