FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 2 results

510(k) Data Aggregation

K Number

Device Name

SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL

Manufacturer

MAXXIM MEDICAL, INC.

Date Cleared

2001-05-17

(28 days)

Product Code

LZA

Regulation Number

880.6250

Why did this record match?

Applicant Name (Manufacturer) :

MAXXIM MEDICAL, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

K Number

Device Name

EUDERMIC PF POWDER-FREE SURGICAL GLOVES

Manufacturer

MAXXIM MEDICAL, INC.

Date Cleared

2000-06-12

(46 days)

Product Code

KGO

Regulation Number

878.4460

Why did this record match?

Applicant Name (Manufacturer) :

MAXXIM MEDICAL, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

Page 1 of 1