Home / 510(k) Clearances / K891727

510(k) K891727

LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD) by Baldur Systems Corp. — Product Code LYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1989
Date Received
March 23, 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 Baldur Systems Corp.

  • K981823 — OPERATING ROOM TOWELS (August 11, 1998)
  • K974347 — BALDUR NON-STERILE COTTON SPONGES (February 10, 1998)
  • K892684 — PATIENT EXAMINATION GLOVES (LATEX) (September 11, 1989)
  • K891728 — LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) (May 25, 1989)
  • K891726 — VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.) (May 12, 1989)

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)