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510(k) K232614

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) by Sri Trang Gloves (Thailand) Public Company Limited — Product Code LZA

K232614 is an FDA 510(k) premarket notification submitted by Sri Trang Gloves (Thailand) Public Company Limited for the device "Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)". The FDA issued a decision of Substantially Equivalent on May 13, 2024. The device falls under product code LZA (Polymer Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Sri Trang Gloves (Thailand) Public Company Limited has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2024
Date Received
August 28, 2023
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 Sri Trang Gloves (Thailand) Public Company Limited

  • K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White) (September 9, 2024)
  • K221165 — Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use wi (November 20, 2022)
  • K212482 — Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black (August 9, 2022)
  • K212309 — Non-sterile, Powder-Free Latex Examination Glove (April 8, 2022)
  • K200539 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemother (April 9, 2020)
  • K193581 — Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Dru (March 20, 2020)

Other clearances for product code LZA

  • K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitril (September 9, 2026)
  • K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs an (September 9, 2026)
  • K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy (September 8, 2026)
  • K261749 — Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy (September 2, 2026)
  • K260794 — NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT E (August 18, 2026)
  • K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile (July 21, 2026)
  • K254285 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – (July 20, 2026)
  • 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)

FDA data resources