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510(k) K222348

JR MEDIC by Jr Engineering & Medical Technologies (M) Sdn. Bhd. — Product Code LYY

K222348 is an FDA 510(k) premarket notification submitted by Jr Engineering & Medical Technologies (M) Sdn. Bhd. for the device "JR MEDIC". The FDA issued a decision of Substantially Equivalent on October 27, 2022. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Jr Engineering & Medical Technologies (M) Sdn. Bhd. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2022
Date Received
August 3, 2022
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 Jr Engineering & Medical Technologies (M) Sdn. Bhd.

  • K222350 — Sterile Nitrile Surgical Gloves Powder Free (April 13, 2023)
  • K221626 — Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemoth (December 7, 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 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)
  • 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)

FDA data resources