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510(k) K100611

RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) by Riverstone Resources Sdn Bhd — Product Code LYY

K100611 is an FDA 510(k) premarket notification submitted by Riverstone Resources Sdn Bhd for the device "RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)". The FDA issued a decision of Substantially Equivalent on Jul 16, 2010. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Riverstone Resources Sdn Bhd has 14 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 16, 2010
Date Received
Mar 3, 2010
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 Riverstone Resources Sdn Bhd

  • K220672 — Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy… (Jun 3, 2022)
  • K220401 — Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy… (Apr 9, 2022)
  • K200326 — Powder Free Nitrile Examination Glove (Aqua Green) (Apr 9, 2020)
  • K190725 — Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim… (Dec 17, 2019)
  • K180452 — White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim (Jun 12, 2018)
  • K152542 — Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim… (Dec 24, 2015)
  • K133193 — RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) (Jun 23, 2014)
  • K112924 — RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY… (May 2, 2012)
  • K112928 — RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER… (Apr 17, 2012)
  • K100603 — RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) (Jul 16, 2010)

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