Home / 510(k) Clearances / K010483

510(k) K010483

POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0 by Pt. Medisafe Technologies — Product Code LYY

K010483 is an FDA 510(k) premarket notification submitted by Pt. Medisafe Technologies for the device "POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0". The FDA issued a decision of Substantially Equivalent on May 3, 2001. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Pt. Medisafe Technologies has 18 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2001
Date Received
Feb 20, 2001
Clearance Type
Special
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 Pt. Medisafe Technologies

  • K201774 — Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential… (Sep 16, 2020)
  • K182176 — Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with… (Mar 28, 2019)
  • K173258 — Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with… (Apr 20, 2018)
  • K163041 — Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E (Feb 22, 2017)
  • K142941 — Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use… (Nov 2, 2015)
  • K142190 — Polychloroprene Powder-free Surgical Glove (White) Tested for Use with… (Jul 14, 2015)
  • K133689 — POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK (Jul 3, 2014)
  • K112654 — POWDERFREE POLYISOPRENE SURGICAL GLOVES (Feb 17, 2012)
  • K102623 — BLUE POWDERFREE NITRILE EXAMINATION GLOVE (Jun 6, 2011)
  • K102620 — POWDERFREE BLACK NITRILE EXAMINATION GLOVES (Nov 22, 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