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510(k) K211478

Sterile Latex Surgical Gloves Powder Free by Aspen Glove Sdn. Bhd. — Product Code KGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2021
Date Received
May 12, 2021
Clearance Type
Abbreviated
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 Aspen Glove Sdn. Bhd.

  • K213076 — AspenMed+ (December 20, 2021)
  • K211477 — Latex Examination Powder Free Gloves (September 20, 2021)
  • K211479 — Blue Nitrile Examination Glove Powder Free (September 16, 2021)

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  • K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Derm (August 23, 2023)
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