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510(k) K924959

STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC by Perlink USA, Inc. — Product Code LYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1993
Date Received
September 30, 1992
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 Perlink USA, Inc.

  • K922358 — STERLING POWDER FREE PATIENT EXAMINATION GLOVES (June 11, 1993)
  • K921438 — DISPOSABLE LATEX EXAMINATION GLOVES (June 23, 1992)
  • K896707 — PERLINK SCREEN, KIRAN SCREEN (August 30, 1990)
  • K901790 — THERMOMETER, MERCURY/CLINICAL (July 11, 1990)
  • K896708 — PERLINK CASSETTE, KIRAN CASSETTE (May 7, 1990)

Other clearances for product code LYY

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  • 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)