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510(k) K023577

POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G) by Yty Industry (Manjung) Sdn Bhd — Product Code LYY

K023577 is an FDA 510(k) premarket notification submitted by Yty Industry (Manjung) Sdn Bhd for the device "POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G)". The FDA issued a decision of Substantially Equivalent on Dec 6, 2002. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Yty Industry (Manjung) Sdn Bhd has 26 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 6, 2002
Date Received
Oct 23, 2002
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
510(k)

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 Yty Industry (Manjung) Sdn Bhd

  • K220644 — Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use… (Mar 25, 2023)
  • K202536 — Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis… (Aug 11, 2021)
  • K200453 — NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL… (May 1, 2020)
  • K182383 — Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy… (Mar 19, 2019)
  • K171104 — Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with… (Aug 25, 2017)
  • K162095 — Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with… (Nov 2, 2016)
  • K143289 — NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND… (Aug 18, 2015)
  • K143055 — Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple… (Feb 12, 2015)
  • K142283 — Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White… (Jan 16, 2015)
  • K133123 — NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F (May 30, 2014)

Other clearances for product code LYY

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

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