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

K Number

K955464

Device Name

TACTYLON POWDER FREE EXAMINATION GLOVE

Manufacturer

TACTYL TECHNOLOGIES, INC.

Date Cleared

1996-04-25

(147 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Tactyl's powder free examination gloves are manufactured using TACTYLON™. TACTYLON™ gloves are made of a synthetic material that mimics latex but contain no natural rubber latex. It is also powder free for those users who will benefit from such requirements. The glove meets the physical property requirements of ASTM 3578-91 Rubber Examination Gloves. The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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K Number

K955419

Device Name

POWDER FREE TACTYLON SURGEONS GLOVE

Manufacturer

TACTYL TECHNOLOGIES, INC.

Date Cleared

1996-04-15

(140 days)

Product Code

KGO

Regulation Number

878.4460

Intended Use

The surgical glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Tactyl's powder free surgical gloves are manufactured using TACTYLON™ TACTYLON™ gloves are made of a synthetic material that mimics latex but contain no natural rubber latex. It is also powder free for those users who will benefit from such requirements. The glove meets the physical property requirements of ASTM 3577-91 Rubber Surgical Gloves, Type II, compounded from a rubber cement or from synthetic rubber latex.

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K Number

K953583

Device Name

LUBRICATED CONDOM

Manufacturer

TACTYL TECHNOLOGIES, INC.

Date Cleared

1996-01-26

(178 days)

Product Code