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510(k) K231643

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) by Syntex Healthcare Products Co., Ltd. — Product Code LZA

K231643 is an FDA 510(k) premarket notification submitted by Syntex Healthcare Products Co., Ltd. for the device "Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)". The FDA issued a decision of Substantially Equivalent on September 8, 2023. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Syntex Healthcare Products Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2023
Date Received
June 5, 2023
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 Syntex Healthcare Products Co., Ltd.

  • K240080 — Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Dr (April 2, 2024)
  • K103770 — SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL (April 21, 2011)
  • K102096 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (October 4, 2010)
  • K052877 — POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE (November 8, 2005)
  • K042226 — SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY (September 30, 2004)
  • K033777 — ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (February 5, 2004)
  • K023826 — SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR (January 24, 2003)
  • K022784 — SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR (November 13, 2002)
  • K022146 — SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE (September 3, 2002)
  • K022092 — SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE (September 3, 2002)

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)
  • K260703 — Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Dr (June 3, 2026)
  • K260806 — Nitrile Disposable Examination Gloves (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