Home / 510(k) Clearances / K221626

510(k) K221626

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate by Jr Engineering & Medical Technologies (M) Sdn. Bhd. — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2022
Date Received
June 6, 2022
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 Jr Engineering & Medical Technologies (M) Sdn. Bhd.

  • K222350 — Sterile Nitrile Surgical Gloves Powder Free (April 13, 2023)
  • K222348 — JR MEDIC (October 27, 2022)
  • K221169 — JR MEDIC Nitrile Examination Gloves Powder Free- Black (October 25, 2022)
  • K222349 — JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) (October 21, 2022)
  • K221157 — JR Medic (August 30, 2022)
  • K212827 — Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemoth (December 6, 2021)
  • K192328 — JR.MEDIK Latex Surgeon’s Gloves Powder Free (March 10, 2020)
  • K192333 — Blue Nitrile Examination Gloves Powder Free (January 24, 2020)
  • K192329 — Blue Latex Examination Powder Free Gloves (November 25, 2019)

Other clearances for product code LZA

  • 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)
  • K251716 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid F (August 27, 2025)
  • K252244 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use Wit (August 21, 2025)
  • K243604 — Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, (August 18, 2025)
  • K251319 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy D (July 30, 2025)
  • K250193 — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opi (July 9, 2025)