FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K980412

Device Name

COLOURED POWDWR-FREE SURGICAL GLOVES

Manufacturer

KENWELL INTERNATIONAL LTD.

Date Cleared

1998-04-08

(64 days)

Product Code

KGO

Regulation Number

878.4460

Intended Use

This device is intended to be used as a single use disposable sterile surgical glove. This Surgeon's Glove is a device made of naturel rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Classified by FDA's General and Plastic Surgery Device Panel as Class 1, 21 CFR 878.4460, Surgical Powder-free Latex Gloves, 79KGO and meets all requirements of ASTM standard D-3577-91.

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K Number

K980803

Device Name

STERILE POWDER-FREE LATEX EXAMINATION GLOVES

Manufacturer

KENWELL INTERNATIONAL LTD.

Date Cleared

1998-04-03

(32 days)

Product Code

LYY

Regulation Number

880.6250

Intended Use

This device is intended to be used as a single use disposable sterile examination glove. This Examination Glove is a device made of natural rubber latex intended to be worn by medical personnel to prevent cross contamination between them and the patient.

Device Description

Classified by FDA's General and Plastic Surgery Device Panel as Class 1, 21 CFR 878.4460, Examination Powder-free Latex Gloves, 80 LYY and meets all requirements of ASTM standard D-3578-95.

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K Number

K963020

Device Name

GLOVEL GX

Manufacturer

KENWELL INTERNATIONAL LTD.

Date Cleared

1996-11-27

(114 days)

Product Code