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510(k) K921438

DISPOSABLE LATEX EXAMINATION GLOVES by Perlink USA, Inc. — Product Code LYY

K921438 is an FDA 510(k) premarket notification submitted by Perlink USA, Inc. for the device "DISPOSABLE LATEX EXAMINATION GLOVES". The FDA issued a decision of Substantially Equivalent on June 23, 1992. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Perlink USA, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1992
Date Received
March 25, 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)
  • K924959 — STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC (March 3, 1993)
  • 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

  • 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