Home / 510(k) Clearances / K940254

510(k) K940254

BIOSHIELD BLUE POWDER FREE GLOVE by Chester Labs, Inc. — Product Code LYY

K940254 is an FDA 510(k) premarket notification submitted by Chester Labs, Inc. for the device "BIOSHIELD BLUE POWDER FREE GLOVE". The FDA issued a decision of Substantially Equivalent on March 23, 1994. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Chester Labs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1994
Date Received
January 21, 1994
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 Chester Labs, Inc.

  • K041060 — E-Z LUBRICATING JELLY (May 7, 2004)
  • K001705 — STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MO (June 29, 2000)
  • K001593 — MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE (June 14, 2000)
  • K944599 — GRAHAM-FIELD CONDUCTIVE ECG SPRAY (May 7, 1996)
  • K944598 — GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL (May 7, 1996)
  • K944600 — GRAHAM-FIELD SALINE ELECTROLYTE GEL (November 20, 1995)
  • K944597 — GRAHAM-FIELD ULTRASOUND SCANNING GEL (June 21, 1995)
  • K944596 — GRAHAM-FIELD ULTRASOUND LOTION (June 7, 1995)
  • K940256 — BIOSHIELD BLUE LATEX GLOVES (March 23, 1994)
  • K841871 — LIQUA-SONIC GEL (March 14, 1985)

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