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510(k) K992162

SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM by Safeskin Corp. — Product Code LZC

K992162 is an FDA 510(k) premarket notification submitted by Safeskin Corp. for the device "SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM". The FDA issued a decision of Substantially Equivalent on August 30, 1999. The device falls under product code LZC (Medical Glove, Specialty), 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
August 30, 1999
Date Received
June 25, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Medical Glove, Specialty
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.

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)
  • K992062 — SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES (August 25, 1999)
  • K991951 — SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, W (July 26, 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 LZC

  • K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff (January 14, 2026)
  • K243959 — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use wi (February 24, 2025)
  • K221157 — JR Medic (August 30, 2022)
  • K222449 — Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs A (August 27, 2022)
  • K220545 — Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy D (May 26, 2022)
  • K220491 — Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy (May 14, 2022)
  • K220353 — Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Dru (March 31, 2022)
  • K213910 — Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy (March 10, 2022)
  • K213325 — Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy (January 28, 2022)
  • K213076 — AspenMed+ (December 20, 2021)

FDA data resources