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510(k) K901608

HPI POWDER FREE NON-STERILE EXAMINATION GLOVES by Hpi, Inc. — Product Code LYY

K901608 is an FDA 510(k) premarket notification submitted by Hpi, Inc. for the device "HPI POWDER FREE NON-STERILE EXAMINATION GLOVES". The FDA issued a decision of Substantially Equivalent on April 20, 1990. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Hpi, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1990
Date Received
April 6, 1990
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 Hpi, Inc.

  • K922116 — POWDER FREE NITRILE GLOVE (February 8, 1993)
  • K915086 — HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES (June 17, 1992)
  • K910383 — HPI SENSI-SHIELD GLOVE KIT (March 20, 1991)
  • K904878 — SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. (March 7, 1991)
  • K905086 — HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES (December 3, 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