Home / 510(k) Clearances / K891440

510(k) K891440

PATIENT EXAMINATION GLOVES (LATEX) by Interpro Intl., Inc. — Product Code LYY

K891440 is an FDA 510(k) premarket notification submitted by Interpro Intl., Inc. for the device "PATIENT EXAMINATION GLOVES (LATEX)". The FDA issued a decision of Substantially Equivalent on May 31, 1989. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Interpro Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1989
Date Received
March 15, 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 Interpro Intl., Inc.

  • K890968 — VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX) (July 31, 1989)
  • K891642 — PATIENT EXAMINATION GLOVES (LATEX) (July 14, 1989)
  • K890891 — LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL) (July 14, 1989)
  • K891438 — PATIENT EXAMINATION GLOVES (LATEX) (May 31, 1989)
  • K881374 — SURGEONS GLOVES (August 5, 1988)
  • K874067 — GUAZE SPONGES (December 14, 1987)
  • K874766 — INTERPRO INT'L, INC. ISOLATION GOWN (December 10, 1987)
  • K874065 — LAPAROTOMY SPONGES (November 4, 1987)
  • K874066 — SURGICAL CAPS (November 4, 1987)
  • K874064 — SHOE COVERS (November 4, 1987)

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