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510(k) K083410

POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM by Wrp Asia Pacific Sdn. Bhd. — Product Code LZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2009
Date Received
November 18, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Medical Glove, Specialty
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.

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  • K161823 — Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Dr (January 23, 2017)
  • K161422 — DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TEST (October 20, 2016)

Other clearances for product code LZC

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