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510(k) K081569

DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS by Dynarex Corporation — Product Code LZA

K081569 is an FDA 510(k) premarket notification submitted by Dynarex Corporation for the device "DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS". The FDA issued a decision of Substantially Equivalent on September 12, 2008. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Dynarex Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2008
Date Received
June 4, 2008
Clearance Type
Abbreviated
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 Dynarex Corporation

  • K172266 — Dynarex Three-Way Stopcock (March 14, 2018)
  • K152970 — Dynarex Xeroform Petrolatum Dressing (October 3, 2016)
  • K151575 — Dynarex Eye Cups (September 1, 2015)
  • K103086 — DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC (June 7, 2011)
  • K102637 — DYNAREX ULTRASOUND GEL (February 16, 2011)
  • K092488 — DYNAREX STERILE LUBRICATING JELLY (December 18, 2009)
  • K082863 — DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING S (January 9, 2009)

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