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K Number
K161008
Device Name
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
Manufacturer
HARTALEGA SDN. BHD.
Date Cleared
2016-07-28

(108 days)

Product Code
KGO
Regulation Number
878.4460
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Polyisoprene Powder Free Surgical Glove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations.
The Polyisoprene Powder Free Surgical Underglove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding surgical gloves and undergloves, and it does not contain the information required to answer the prompt.

The document discusses:

  • The FDA's review and determination of substantial equivalence for two medical devices: "Polyisoprene Powder Free Surgical Underglove" and "Polyisoprene Powder Free Surgical Glove."
  • General regulatory requirements for medical devices, such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
  • Indications for Use for both devices, stating they are disposable devices intended to be worn on hands in surgical settings to provide a barrier against potentially infectious materials and other contaminations.
  • That both devices are for "Over-The-Counter Use."

The document does not include:

  • A table of acceptance criteria and reported device performance.
  • Information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about training sets.

Therefore, I cannot provide the requested details based on the given input.

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).