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510(k) K252244

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid by Ever Global (Vietnam) Enterprise Corporation — Product Code LZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2025
Date Received
July 18, 2025
Clearance Type
Special
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 Ever Global (Vietnam) Enterprise Corporation

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  • K221980 — Disposable Powder Free Vinyl Examination Gloves, Beige/Clear (February 6, 2023)
  • K220992 — Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple (October 19, 2022)
  • K190403 — Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Che (September 6, 2019)

Other clearances for product code LZA

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  • 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)
  • 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)
  • K250342 — Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with (July 8, 2025)