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510(k) K223298

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) by Shandong Intco Medical Products Co, Ltd. — Product Code LYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2023
Date Received
October 27, 2022
Clearance Type
Traditional
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 Shandong Intco Medical Products Co, Ltd.

  • K233042 — Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy (December 6, 2023)
  • K231408 — Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile (August 11, 2023)
  • K213509 — Latex Examination Gloves, Powder Free (April 8, 2022)

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)
  • 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)
  • K211601 — Powder Free Latex Examination Glove, Non-Sterile (August 22, 2022)