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510(k) K897128

UMI BRAIDED CATHETER CONNECTOR by Universal Medical Instrument Corp. — Product Code LYY

K897128 is an FDA 510(k) premarket notification submitted by Universal Medical Instrument Corp. for the device "UMI BRAIDED CATHETER CONNECTOR". The FDA issued a decision of Substantially Equivalent on March 1, 1990. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Universal Medical Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1990
Date Received
December 26, 1989
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 Universal Medical Instrument Corp.

  • K962180 — CATH SEAL (November 7, 1996)
  • K935077 — CATH-SEAL (June 7, 1994)
  • K881796 — UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE (July 26, 1988)
  • K863178 — UMI STEERABLE TORQUE GUIDE WIRE (September 19, 1986)
  • K861984 — UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO (August 5, 1986)
  • K860168 — UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE (February 19, 1986)
  • K851088 — UMI ANGIOGRAPHIC CATHETER (May 16, 1985)
  • K850820 — PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID (April 10, 1985)
  • K844558 — UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE (January 31, 1985)
  • K842259 — PCI W/CATH-SEAL SIDE FLOW FITTING (August 1, 1984)

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)

FDA data resources