Home / 510(k) Clearances / K171898

510(k) K171898

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs by Better Care Plastic Technology Co., Ltd. — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2017
Date Received
June 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgeon'S Gloves
Device Class
Class I
Regulation Number
878.4460
Review Panel
HO
Submission Type

A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Other clearances by Better Care Plastic Technology Co., Ltd.

  • K242533 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low D (March 18, 2025)
  • K232266 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Teste (November 3, 2023)
  • K232070 — Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (October 11, 2023)
  • K231567 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemoth (October 4, 2023)
  • K223713 — Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Dr (August 7, 2023)
  • K222449 — Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs A (August 27, 2022)
  • K221269 — Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy D (July 27, 2022)
  • K182600 — Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (B (November 30, 2018)
  • K171047 — Sterile Polyisoprene Powder Free Surgical Gloves (June 22, 2017)
  • K140816 — POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (B (July 8, 2014)

Other clearances for product code KGO

  • K250313 — Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For U (August 19, 2025)
  • K240790 — Polyisoprene Surgical gloves (August 23, 2024)
  • K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with C (March 28, 2024)
  • K232444 — Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drug (December 20, 2023)
  • K231902 — GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX P (October 20, 2023)
  • K231973 — PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove (September 29, 2023)
  • K231446 — Single-Use Latex Sterile Surgical Gloves (SG100) (September 22, 2023)
  • K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with (August 31, 2023)
  • K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Derm (August 23, 2023)
  • K222993 — Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green (August 18, 2023)