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510(k) K982901

LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED by Vitalcare Group, Inc. — Product Code LYY

K982901 is an FDA 510(k) premarket notification submitted by Vitalcare Group, Inc. for the device "LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED". The FDA issued a decision of Substantially Equivalent on December 21, 1998. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Vitalcare Group, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1998
Date Received
August 17, 1998
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 Vitalcare Group, Inc.

  • K060109 — OMI RETRACTABLE SAFETY SYRINGE (May 5, 2006)
  • K050906 — VITALCARE I.V. ADMINISTRATION SET (August 23, 2005)
  • K040916 — VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE (May 4, 2005)
  • K031748 — VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES (August 27, 2003)
  • K992289 — VINYL POWDERED EXAM GLOVE / CAT.# 15-020 (August 4, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983716 — VITALCARE DISPOSABLE VAGINAL SPECULUM (December 23, 1998)

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