FDA 510(k)

RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)

K-Number: K100611 · 2010-07-16

Decision Date2010-07-16

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) is the device name listed in this FDA 510(k) record. The listed applicant is Riverstone Resources Sdn Bhd. It received FDA 510(k) clearance on 2010-07-16 under 510(k) number K100611. 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 RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)?

RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) is a medical device that received FDA 510(k) clearance on 2010-07-16. The listed applicant is Riverstone Resources Sdn Bhd. The 510(k) number is K100611.

When did RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) receive FDA 510(k) clearance?

RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) received FDA 510(k) clearance on 2010-07-16, under 510(k) number K100611.

Who is the listed applicant for RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)?

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

What is the FDA product code for RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)?

The FDA product code for RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) is LYY.

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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.