Home / 510(k) Clearances / K915140

510(k) K915140

PRIMARY DRESSING TRAY by Mediflex Intl. — Product Code LYY

K915140 is an FDA 510(k) premarket notification submitted by Mediflex Intl. for the device "PRIMARY DRESSING TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on February 11, 1992. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Mediflex Intl. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
February 11, 1992
Date Received
November 13, 1991
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 Mediflex Intl.

  • K900841 — HEMODIALYSIS TRANSDUCER PROTECTOR (May 15, 1990)
  • K891077 — MEDIVERSE PARENTERAL NUTRITION BAG (May 24, 1989)
  • K884243 — BLOOD TUBING SET (December 8, 1988)
  • K863496 — MEDIFLEX TRANSDUCER PROTECTOR (September 23, 1986)
  • K855039 — MEDIFLEX INJECTION CAP (January 24, 1986)
  • K854346 — MEDIFLEX DISPOSABLE TUBING CLAMP (November 18, 1985)
  • K852106 — I.V. ADMINISTRATION SET (June 7, 1985)
  • K843126 — MEDIFLEX DRAINAGE BAG (October 4, 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