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510(k) K893334

PREPOWDERED VINYL EXAM GLOVES by Dynarex Corp. — Product Code LYZ

K893334 is an FDA 510(k) premarket notification submitted by Dynarex Corp. for the device "PREPOWDERED VINYL EXAM GLOVES". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code LYZ (Vinyl Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Dynarex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
April 20, 1989
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 Dynarex Corp.

  • K052743 — DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 (December 22, 2005)
  • K052314 — DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE (November 9, 2005)
  • K012816 — DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 (October 17, 2002)
  • K012957 — TOWEL DRAPE, MODELS 4409, 4410 (March 6, 2002)
  • K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (November 28, 2001)
  • K991694 — DYNAREX DRAIN SPONGE (July 15, 1999)
  • K991695 — DYNAREX NON-WOVEN SPONGE (July 15, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K960388 — DYNAREX NON-WOVEN SPONGE (April 1, 1996)
  • K951660 — DYNAREX GAUZE SPONGE (May 9, 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