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510(k) K011293

POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES by Multisafe Sdn. Bhd. — Product Code LYY

K011293 is an FDA 510(k) premarket notification submitted by Multisafe Sdn. Bhd. for the device "POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES". The FDA issued a decision of Substantially Equivalent on Jul 10, 2001. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Multisafe Sdn. Bhd. has 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 10, 2001
Date Received
Apr 30, 2001
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 Multisafe Sdn. Bhd.

  • K161085 — Nitrile Patient Examination Powder Free Glove, Textured, Black (Jul 5, 2018)
  • K062526 — BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE (Apr 13, 2007)
  • K062527 — BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (Feb 20, 2007)
  • K001619 — MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) (Jul 26, 2000)
  • K001497 — MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) (Jul 26, 2000)
  • K000999 — MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT… (May 22, 2000)
  • K993811 — MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE (Mar 2, 2000)

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)

FDA data resources