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510(k) K232538

DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL by Wrp Asia Pacific Sdn. Bhd. — Product Code LZA

K232538 is an FDA 510(k) premarket notification submitted by Wrp Asia Pacific Sdn. Bhd. for the device "DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL". The FDA issued a decision of Substantially Equivalent on November 17, 2023. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Wrp Asia Pacific Sdn. Bhd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2023
Date Received
August 22, 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 Wrp Asia Pacific Sdn. Bhd.

  • K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with C (March 28, 2024)
  • K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with (August 31, 2023)
  • K222058 — Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemother (October 22, 2022)
  • K211601 — Powder Free Latex Examination Glove, Non-Sterile (August 22, 2022)
  • K210330 — Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with C (March 4, 2022)
  • K203030 — POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DR (June 11, 2021)
  • K192635 — Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) (January 17, 2020)
  • 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)
  • K141982 — DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TEST (February 5, 2015)

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