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510(k) K991951

SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE) by Safeskin Corp. — Product Code LYZ

K991951 is an FDA 510(k) premarket notification submitted by Safeskin Corp. for the device "SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)". The FDA issued a decision of Substantially Equivalent on July 26, 1999. The device falls under product code LYZ (Vinyl Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Safeskin Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1999
Date Received
June 10, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vinyl Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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 Safeskin Corp.

  • K993117 — SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG O (March 2, 2000)
  • K994081 — SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES (January 18, 2000)
  • K992830 — SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NIT (October 27, 1999)
  • K992210 — SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES (September 10, 1999)
  • K992162 — SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPE (August 30, 1999)
  • K992062 — SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES (August 25, 1999)
  • K991317 — POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF T (May 21, 1999)
  • K970899 — SAFESKIN POWDERED EXAMINATION GLOVE (May 6, 1997)
  • K962139 — SAFESKIN (December 19, 1996)
  • K953015 — SAFESKIN SUPRA (August 28, 1995)

Other clearances for product code LYZ

  • K260860 — Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) (April 7, 2026)
  • K252467 — Disposable Vinyl Examination Gloves (October 27, 2025)
  • K252505 — Powder-Free Vinyl Exam Gloves, clear (August 28, 2025)
  • K241252 — Disposable Vinyl Examination Gloves (May 20, 2024)
  • K230046 — Vinyl examination gloves (March 25, 2023)
  • K221980 — Disposable Powder Free Vinyl Examination Gloves, Beige/Clear (February 6, 2023)
  • K220992 — Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple (October 19, 2022)
  • K223008 — Disposable Vinyl Examination Gloves (October 8, 2022)
  • K222442 — DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) (September 28, 2022)
  • K220055 — Disposable, vinyl examination gloves, Yellow (August 25, 2022)

FDA data resources