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510(k) K212309

Non-sterile, Powder-Free Latex Examination Glove by Sri Trang Gloves (Thailand) Public Company Limited — Product Code LYY

K212309 is an FDA 510(k) premarket notification submitted by Sri Trang Gloves (Thailand) Public Company Limited for the device "Non-sterile, Powder-Free Latex Examination Glove". The FDA issued a decision of Substantially Equivalent on April 8, 2022. The device falls under product code LYY (Latex 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
April 8, 2022
Date Received
July 23, 2021
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Latex Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A latex patient examination glove is a disposable device made of natural rubber latex 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)
  • K232614 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemother (May 13, 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)
  • 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 LYY

  • K250069 — Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Prot (April 29, 2025)
  • K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White) (September 9, 2024)
  • K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Pr (June 13, 2023)
  • K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (February 22, 2023)
  • K222612 — Powder-Free Latex examination gloves (November 25, 2022)
  • K221667 — Non Sterile Powder Free Latex Examination Glove (October 28, 2022)
  • K222348 — JR MEDIC (October 27, 2022)
  • K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (October 26, 2022)
  • K222693 — Single-use medical latex examination gloves (LG100) (September 24, 2022)
  • K221648 — Iconic Latex Glove (August 25, 2022)

FDA data resources