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510(k) K891712

PERRY* LATEX FLOOR GLOVES by Smith & Nephew Medical — Product Code LYY

K891712 is an FDA 510(k) premarket notification submitted by Smith & Nephew Medical for the device "PERRY* LATEX FLOOR GLOVES". The FDA issued a decision of Substantially Equivalent on April 27, 1989. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Smith & Nephew Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1989
Date Received
March 20, 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 Smith & Nephew Medical

  • K260646 — RENASYS EDGE (66803126) (May 27, 2026)
  • K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (September 11, 2025)
  • K243576 — RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS G (February 18, 2025)
  • K231939 — Renasys Edge (May 24, 2024)
  • K190730 — IODOSORB (December 20, 2019)
  • K190756 — IODOFLEX (December 20, 2019)
  • K153209 — RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS (August 4, 2016)
  • K151436 — PICO Single Use Negative Pressure Wound Therapy System (January 28, 2016)
  • K891444 — PERRY* STERILE X-AM* GLOVES (September 19, 1989)
  • K892353 — PERRY* NON-STERILE X-AM* GLOVES (May 25, 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)

FDA data resources