FDA 510(k)

SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE

K-Number: K062313 · 2006-11-30

Decision Date2006-11-30

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Pt Mahakarya Inti Buana. It received FDA 510(k) clearance on 2006-11-30 under 510(k) number K062313. 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 SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE?

SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE is a medical device that received FDA 510(k) clearance on 2006-11-30. The listed applicant is Pt Mahakarya Inti Buana. The 510(k) number is K062313.

When did SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE receive FDA 510(k) clearance?

SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE received FDA 510(k) clearance on 2006-11-30, under 510(k) number K062313.

Who is the listed applicant for SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE?

The FDA 510(k) record lists Pt Mahakarya Inti Buana as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE?

The FDA product code for SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE is LYY.

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Other records listing Pt Mahakarya Inti Buana as applicant

K111300SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)K090464BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE K063581SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE K061233SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE K053305SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE K053366NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE

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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.