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510(k) K893520

DR. BOO LATEX EXAMINATION GLOVES by Dynatech Medical Products — Product Code LYY

K893520 is an FDA 510(k) premarket notification submitted by Dynatech Medical Products for the device "DR. BOO LATEX EXAMINATION GLOVES". The FDA issued a decision of Substantially Equivalent on August 21, 1989. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Dynatech Medical Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1989
Date Received
May 8, 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 Dynatech Medical Products

  • K923187 — IMPERVIOUS ISOLATION SHOE COVERS (January 29, 1993)
  • K923188 — DYNASTY IMPERVIOUS ISOLATION J-SUIT (January 29, 1993)
  • K922234 — DYNASTY ISOLATION GOWN (August 11, 1992)
  • K770730 — PUMP, INFUSION, DYNATECH/HANDLEY (July 11, 1977)

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