Home / 510(k) Clearances / K002065

510(k) K002065

PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR by Comfort Rubber Gloves Industries Sdn. Bhd. — Product Code LYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2000
Date Received
July 7, 2000
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 Comfort Rubber Gloves Industries Sdn. Bhd.

  • K250069 — Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Prot (April 29, 2025)
  • K240269 — Nitrile Powder Free Examination Gloves Biodegradable (Green) (October 25, 2024)
  • K241528 — Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potent (August 6, 2024)
  • K192954 — Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and (June 19, 2020)
  • K200181 — Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemoth (April 15, 2020)
  • K190080 — Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs La (June 27, 2019)
  • K180476 — Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (May 15, 2018)
  • K171541 — Powder Free Nitrile Examination Gloves (Orange) (September 20, 2017)
  • K162405 — Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs La (March 28, 2017)
  • K110297 — POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES (June 15, 2011)

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)
  • 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)