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510(k) K190159

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove by Showa Best Glove, Inc. — Product Code LZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2019
Date Received
January 30, 2019
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 Showa Best Glove, Inc.

  • K211003 — SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove (January 19, 2022)
  • K180468 — SBG Black Nitrile Powder Free Medical Examination Glove (October 10, 2018)
  • K180467 — SBG Blue Nitrile Powder Free Medical Examination Glove (October 10, 2018)

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)