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510(k) K110979

DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS by Advanced Medical Products Sdn Bhd — Product Code LZA

K110979 is an FDA 510(k) premarket notification submitted by Advanced Medical Products Sdn Bhd for the device "DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS". The FDA issued a decision of Substantially Equivalent on October 20, 2011. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Advanced Medical Products Sdn Bhd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2011
Date Received
April 7, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Other clearances by Advanced Medical Products Sdn Bhd

  • K000932 — ARACHNOPHLEBECTOMY NEEDLE (May 17, 2000)
  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K921426 — ULTRA PCI (October 5, 1992)
  • K912925 — ULTRA PVD (June 18, 1992)
  • K915658 — SPECTRA ECG (June 10, 1992)
  • K896102 — MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR (January 18, 1990)
  • K896103 — MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR (January 18, 1990)
  • K881905 — MODEL MICRO SI AMBULATORY ECG MONITOR (August 2, 1988)
  • K872508 — MODEL MICRO FD+ AMBULATORY ECG MONITOR (September 25, 1987)
  • K870537 — MODEL MICRO ST AMBULATORY ECG MONITOR (April 23, 1987)

Other clearances for product code LZA

  • K252117 — Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use (June 24, 2026)
  • K253824 — Powder Free Nitrile Examination Gloves Non-Sterile Black (June 18, 2026)
  • K260867 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs an (June 17, 2026)
  • K260806 — Nitrile Disposable Examination Gloves (June 3, 2026)
  • K260703 — Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Dr (June 3, 2026)
  • K253160 — Syntex Exam Gloves (January 23, 2026)
  • K252549 — Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tes (January 13, 2026)
  • K251141 — Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested (November 17, 2025)
  • K250861 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fe (October 23, 2025)
  • K252075 — Program insite® Powder-Free, Disposable Nitrile Exam Gloves (October 17, 2025)

FDA data resources